82_FR_19816 82 FR 19735 - Determination That DEMEROL (Meperidine Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

82 FR 19735 - Determination That DEMEROL (Meperidine Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 81 (April 28, 2017)

Page Range19735-19737
FR Document2017-08582

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. Through this notice, FDA is hoping to stimulate the economy and increase the regulatory certainty with respect to generic versions of these drug products by confirming that generic versions of the subject drug products may continue to be marketed.

Federal Register, Volume 82 Issue 81 (Friday, April 28, 2017) 
[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)]
[Notices]
[Pages 19735-19737]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08582]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1551]


Determination That DEMEROL (Meperidine Hydrochloride) Injectable 
and Other Drug Products Were Not Withdrawn From Sale for Reasons of 
Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that the drug products listed in this document were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination means that FDA will not begin procedures to withdraw 
approval of abbreviated new drug applications (ANDAs) that refer to 
these drug products, and it will allow FDA to continue to approve ANDAs 
that refer to the products as long as they meet relevant legal and 
regulatory requirements. Through this notice, FDA is hoping to 
stimulate the economy and increase the regulatory certainty with 
respect to generic versions of these drug products by confirming that 
generic versions of the subject drug products may continue to be 
marketed.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
[email protected].

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
applicants must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the ``listed drug,'' which is a 
version of the drug that was previously approved. ANDA applicants do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is generally known as the ``Orange 
Book.'' Under FDA regulations, a drug is removed from the list if the 
Agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness, or if FDA determines that the 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must 
determine whether a listed drug was withdrawn from sale for reasons of 
safety or effectiveness: (1) Before an ANDA that refers to that listed 
drug may be approved, (2) whenever a listed drug is voluntarily 
withdrawn from sale and ANDAs that refer to the listed drug have been 
approved, and (3) when a person petitions for such a determination 
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if 
FDA determines that a listed drug was withdrawn from sale for safety or

[[Page 19736]]

effectiveness reasons, the Agency will initiate proceedings that could 
result in the withdrawal of approval of the ANDAs that refer to the 
listed drug.
    FDA has become aware that the drug products listed in the table in 
this document are no longer being marketed.

----------------------------------------------------------------------------------------------------------------
                                               Active                           Dosage form/
    Application No.         Drug name       ingredient(s)      Strength(s)          route           Applicant
----------------------------------------------------------------------------------------------------------------
NDA 005010............  DEMEROL.........  Meperidine        50 milligrams     Syrup; Oral.....  U.S.
                                           Hydrochloride.    (mg)/5                              Pharmaceutical
                                                             milliliter (mL).                    Holdings II,
                                                                                                 LLC.
NDA 006035............  METHERGINE......  Methylergonovine  0.2 mg..........  Tablet; Oral....  Edison
                                           Maleate.                                              Therapeutics
                                                                                                 LLC.
NDA 007337............  PERCODAN and      Aspirin,          325 mg, 4.5 mg,   Tablet; Oral....  Endo
                         PERCODAN-DEMI.    Oxycodone         0.38 mg; and                        Pharmaceuticals
                                           Hydrochloride,    325 mg, 2.25                        Inc.
                                           Oxycodone         mg, 0.19 mg.
                                           Terephthalate.
NDA 008720............  LEVO-DROMORAN...  Levorphanol       2 mg............  Tablet; Oral....  Valeant
                                           Tartrate.                                             Pharmaceuticals
                                                                                                 North America
                                                                                                 LLC.
NDA 008848............  PAMINE and        Methscopolamine   2.5 mg and 5 mg.  Tablet; Oral....  Fougera
                         PAMINE FORTE.     Bromide.                                              Pharmaceuticals
                                                                                                 Inc.
NDA 009470............  XYLOCAINE         Lidocaine         2%..............  Solution; Oral..  Fresenius Kabi
                         VISCOUS.          Hydrochloride.                                        USA, LLC.
NDA 010485............  ATARAX..........  Hydroxyzine       10 mg/5 mL......  Syrup; Oral.....  Pfizer Inc.
                                           Hydrochloride.
NDA 010742............  COMPAZINE.......  Prochlorperazine  Equivalent to     Injectable;       GlaxoSmithKline.
                                           Edisylate.        (EQ) 5 mg Base/   Injection.
                                                             mL.
NDA 012111............  MYDRIACYL.......  Tropicamide.....  0.5%; 1%........  Solution/Drops;   Alcon
                                                                               Ophthalmic.       Laboratories
                                                                                                 Inc.
NDA 012248............  PLEGINE.........  Phendimetrazine   35 mg...........  Tablet; Oral....  Wyeth Ayerst
                                           Tartrate.                                             Laboratories.
NDA 012365............  SOMA COMPOUND...  Aspirin;          325 mg; 200 mg..  Tablet; Oral....  Meda
                                           Carisoprodol.                                         Pharmaceuticals
                                                                                                 Inc.
NDA 012366............  SOMA COMPOUND W/  Aspirin;          325 mg; 200 mg;   Tablet; Oral....  Ditto.
                         CODEINE.          Carisoprodol;     16 mg.
                                           Codeine
                                           Phosphate.
NDA 016012............  VIVACTIL........  Protriptyline     5 mg; 10 mg.....  Tablet; Oral....  Teva Women's
                                           Hydrochloride.                                        Health, Inc.
NDA 017352............  FASTIN..........  Phentermine       30 mg...........  Capsule; Oral...  GlaxoSmithKline.
                                           Hydrochloride.
NDA 017690............  IMODIUM.........  Loperamide        2 mg............  Capsule; Oral...  Johnson &
                                           Hydrochloride.                                        Johnson
                                                                                                 Consumer Inc.
NDA 017694............  IMODIUM.........  Loperamide        2 mg............  Capsule; Oral...  Ditto.
                                           Hydrochloride.
NDA 017741............  FLORONE.........  Diflorasone       0.05%...........  Cream; Topical..  Pharmacia and
                                           Diacetate.                                            Upjohn Co.
NDA 017802............  LO/OVRAL-28.....  Ethinyl           0.03 mg; 0.3 mg.  Tablet; Oral-28.  Wyeth
                                           Estradiol;                                            Pharmaceuticals
                                           Norgestrel.                                           Inc.
NDA 017857............  STADOL..........  Butorphanol       2 mg/mL.........  Injectable;       Delcor Asset
                                           Tartrate.                           Injection.        Corporation.
NDA 017857............  STADOL            Butorphanol       1 mg/mL; 2 mg/mL  Injectable;       Ditto.
                         PRESERVATIVE      Tartrate.                           Injection.
                         FREE.
NDA 018342............  WELLCOVORIN.....  Leucovorin        EQ 5 mg Base; EQ  Tablet; Oral....  GlaxoSmithKline.
                                           Calcium.          25 mg Base.
NDA 018353............  FLAGYL I.V......  Metronidazole     EQ 500 mg Base/   Injectable;       G.D. Searle LLC,
                                           Hydrochloride.    Vial.             Injection.        a subsidiary of
                                                                                                 Pfizer Inc.
NDA 018733............  TALWIN NX.......  Naloxone          EQ 0.5 mg Base;   Tablet; Oral....  Sanofi-Aventis
                                           Hydrochloride;    EQ 50 mg Base.                      U.S. LLC.
                                           Pentazocine
                                           Hydrochloride.
NDA 019488............  CARDENE.........  Nicardipine       20 mg; 30 mg....  Capsule; Oral...  Chiesi USA, Inc.
                                           Hydrochloride.
NDA 019578............  MEFLOQUINE        Mefloquine        250 mg..........  Tablet; Oral....  U.S. Army Walter
                         HYDROCHLORIDE.    Hydrochloride.                                        Reed Army
                                                                                                 Institute
                                                                                                 Research.
NDA 019591............  LARIAM..........  Mefloquine        250 mg..........  Tablet; Oral....  Hoffmann-La
                                           Hydrochloride.                                        Roche Inc.
NDA 019735............  FLOXIN..........  Ofloxacin.......  200 mg; 300 mg;   Tablet; Oral....  Janssen
                                                             400 mg.                             Pharmaceuticals
                                                                                                 , Inc.
NDA 019890............  STADOL..........  Butorphanol       1 mg/Spray......  Spray, Metered;   Bristol-Myers
                                           Tartrate.                           Nasal.            Squibb Co.
NDA 020142............  CATAFLAM........  Diclofenac        50 mg...........  Tablet; Oral....  Novartis
                                           Potassium.                                            Pharmaceuticals
                                                                                                 Corp.
NDA 020254............  VOLTAREN-XR.....  Diclofenac        100 mg..........  Extended-Release  Ditto.
                                           Sodium.                             Tablet; Oral.
NDA 020312............  UNIVASC.........  Moexipril         7.5 mg; 15 mg...  Tablet; Oral....  UCB, Inc.
                                           Hydrochloride.
NDA 020346............  ZYRTEC..........  Cetirizine        5 mg/5 mL.......  Syrup; Oral.....  Johnson &
                                           Hydrochloride.                                        Johnson
                                                                                                 Consumer Inc.
NDA 020584............  LODINE XL.......  Etodolac........  400 mg; 500 mg;   Extended-Release  Wyeth
                                                             600 mg.           Tablet; Oral.     Pharmaceuticals
                                                                                                 Inc.
NDA 020625............  ALLEGRA.........  Fexofenadine      60 mg...........  Capsule; Oral...  Sanofi-Aventis
                                           Hydrochloride.                                        U.S. LLC.
NDA 020729............  UNIRETIC........  Hydro             12.5 mg/7.5 mg;   Tablet; Oral....  UCB, Inc.
                                           chlorothiazide;   12.5 mg/15 mg;
                                           Moexipril         25 mg/15 mg.
                                           Hydrochloride.
NDA 021066............  ZADITOR.........  Ketotifen         EQ 0.025% Base..  Solution/Drops;   Alcon
                                           Fumarate.                           Ophthalmic.       Pharmaceuticals
                                                                                                 , Ltd.
NDA 021224............  RAZADYNE........  Galantamine       4 mg/mL.........  Solution; Oral..  Janssen
                                           Hydrobromide.                                         Pharmaceuticals
                                                                                                 , Inc.
NDA 021378............  COMBUNOX........  Ibuprofen;        400 mg; 5 mg....  Tablet; Oral....  Forest
                                           Oxycodone                                             Laboratories,
                                           Hydrochloride.                                        Inc.
NDA 021473............  CIPRO XR........  Ciprofloxacin;    212.6 mg; EQ      Extended-Release  Bayer HealthCare
                                           Ciprofloxacin     287.5 mg Base;    Tablet; Oral.     Pharmaceuticals
                                           Hydrochloride.    425.2 mg; EQ                        , Inc.
                                                             574.9 mg Base.
NDA 021606............  ZEMPLAR.........  Paricalcitol....  4 micrograms      Capsule; Oral...  AbbVie Inc.
                                                             (mcg).
NDA 021729............  ABILIFY.........  Aripiprazole....  10 mg and 15 mg.  Tablet, Orally    Otsuka
                                                                               Disintegrating;   Pharmaceutical
                                                                               Oral.             Co., Ltd.

[[Page 19737]]

 
NDA 050072............  PENBRITIN-S.....  Ampicillin        EQ 125 mg Base/   Injectable;       Wyeth Ayerst
                                           Sodium.           Vial; EQ 250 mg   Injection.        Laboratories.
                                                             Base/Vial; EQ
                                                             500 mg Base/
                                                             Vial; EQ 1 gram
                                                             (g) Base/Vial;
                                                             EQ 2 g Base/
                                                             Vial; EQ 4 g
                                                             Base/Vial.
NDA 050309............  POLYCILLIN-N....  Ampicillin        EQ 125 mg Base/   Injectable;       Bristol
                                           Sodium.           Vial; EQ 250 mg   Injection.        Laboratories
                                                             Base/Vial; EQ                       Inc.
                                                             500 mg Base/
                                                             Vial; EQ 1 g
                                                             Base/Vial; EQ 2
                                                             g Base/Vial.
NDA 050674............  VANTIN..........  Cefpodoxime       EQ 100 mg Base;   Tablet; Oral....  Pharmacia and
                                           Proxetil.         EQ 200 mg Base.                     Upjohn Co.
ANDA 064170...........  CEFAZOLIN SODIUM  Cefazolin Sodium  EQ 10 g Base/     Injectable;       Fresenius Kabi
                                                             Vial; EQ 20 g     Injection.        USA, LLC.
                                                             Base/Vial.
ANDA 075406...........  OGESTREL 0.5/50-  Ethinyl           0.05 mg; 0.5 mg.  Tablet; Oral-21.  Watson
                         21.               Estradiol;                                            Laboratories,
                                           Norgestrel.                                           Inc.
ANDA 085106...........  PERCOCET........  Acetaminophen;    325 mg; 5 mg....  Tablet; Oral....  Vintage
                                           Oxycodone                                             Pharmaceuticals
                                           Hydrochloride.                                        LLC.
ANDA 089351...........  ROXICET.........  Acetaminophen;    325 mg/5 mL; 5    Solution; Oral..  West-Ward
                                           Oxycodone         mg/5 mL.                            Pharmaceuticals
                                           Hydrochloride.                                        International
                                                                                                 Ltd.
ANDA 089456...........  PERPHENAZINE....  Perphenazine....  8 mg............  Tablet; Oral....  ANI
                                                                                                 Pharmaceuticals
                                                                                                 , Inc.
ANDA 089457...........  PERPHENAZINE....  Perphenazine....  16 mg...........  Tablet; Oral....  Teva
                                                                                                 Pharmaceuticals
                                                                                                 USA.
ANDA 089707...........  PERPHENAZINE....  Perphenazine....  2 mg............  Tablet; Oral....  Ditto.
ANDA 089708...........  PERPHENAZINE....  Perphenazine....  4 mg............  Tablet; Oral....  Do.
----------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug products listed in this document were not 
withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the Agency will continue to list the drug products listed 
in this document in the ``Discontinued Drug Product List'' section of 
the Orange Book. The ``Discontinued Drug Product List'' identifies, 
among other items, drug products that have been discontinued from 
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs and ANDAs listed in this 
document are unaffected by the discontinued marketing of the products 
subject to those NDAs and ANDAs. Additional ANDAs that refer to these 
products may also be approved by the Agency if they comply with 
relevant legal and regulatory requirements. If FDA determines that 
labeling for these drug products should be revised to meet current 
standards, the Agency will advise ANDA applicants to submit such 
labeling.
    This is not a significant regulatory action subject to Executive 
Order 12866, and does not impose any additional burden on regulated 
entities.

    Dated: April 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08582 Filed 4-27-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices 19735 performing the evaluation, procedure Information Collection: Ambulatory FDA to continue to approve ANDAs that and follow-up necessary to ensure Surgical Center Conditions for Coverage; refer to the products as long as they optimal patient outcomes. In accordance Use: The Ambulatory Surgical Center meet relevant legal and regulatory with this criteria, we consider coverage (ASC) Conditions for Coverage (CfCs) requirements. Through this notice, FDA for CAS reasonable and necessary focus on a patient-centered, outcome- is hoping to stimulate the economy and (section 1862(A)(1)(a) of the Social oriented, and transparent processes that increase the regulatory certainty with Security Act). Form Number: CMS– promote quality patient care. The CfCs respect to generic versions of these drug 10199 (OMB control number: 0938– are designed to ensure that each facility products by confirming that generic 1011); Frequency: Yearly; Affected has properly trained staff to provide the versions of the subject drug products Public: Business or other for-profit and appropriate type and level of care for may continue to be marketed. Not-for-profit institutions; Number of that facility and provide a safe physical FOR FURTHER INFORMATION CONTACT: Respondents: 1,370; Total Annual environment for patients. The CfCs are Stacy Kane, Center for Drug Evaluation Responses: 4,110; Total Annual Hours: used by Federal or state surveyors as a and Research, Food and Drug 28,998. (For policy questions regarding basis for determining whether an ASC Administration, 10903 New Hampshire this collection contact Sarah Fulton at qualifies for approval or re-approval Ave., Bldg. 51, Rm. 6236, Silver Spring, 410–786–2749.) under Medicare. We, along with the MD 20993–0002, 301–796–8363, 3. Type of Information Collection healthcare industry, believe that the Stacy.Kane@fda.hhs.gov. Request: Extension of a currently availability to the facility of the type of SUPPLEMENTARY INFORMATION: In 1984, approved collection; Title of records and general content of records, Information Collection: Conditions of Congress enacted the Drug Price which this regulation specifies, is Coverage for Organ Procurement Competition and Patent Term standard medical practice and is Organizations and Supporting Restoration Act of 1984 (Pub. L. 98–417) necessary in order to ensure the well- Regulations; Use: Section 1138(b) of the (the 1984 amendments), which being and safety of patients and Social Security Act, as added by section authorized the approval of duplicate professional treatment accountability. 9318 of the Omnibus Budget versions of drug products approved Form Number: CMS–10279 (OMB Reconciliation Act of 1986 (Pub. L. 99– control number: 0938–1071); Frequency: under an ANDA procedure. ANDA 509), sets forth the statutory Annual; Affected Public: Business or applicants must, with certain qualifications and requirements that other for-profit and Not-for-profit exceptions, show that the drug for organ procurement organizations institutions; Number of Respondents: which they are seeking approval (OPOs) must meet in order for the costs 5,500; Total Annual Responses: 5,500; contains the same active ingredient in of their services in procuring organs for Total Annual Hours: 209,000. (For the same strength and dosage form as transplant centers to be reimbursable policy questions regarding this the ‘‘listed drug,’’ which is a version of under the Medicare and Medicaid collection contact Jacqueline Leach at the drug that was previously approved. programs. An OPO must be certified and 410–786–4282.) ANDA applicants do not have to repeat designated by the Secretary as an OPO the extensive clinical testing otherwise Dated: April 26, 2017. necessary to gain approval of a new and must meet performance-related William N. Parham, III, drug application (NDA). standards prescribed by the Secretary. Director, Paperwork Reduction Staff, Office The 1984 amendments include what The corresponding regulations are of Strategic Operations and Regulatory is now section 505(j)(7) of the Federal found at 42 CFR part 486 (Conditions Affairs. for Coverage of Specialized Services Food, Drug, and Cosmetic Act (21 U.S.C. [FR Doc. 2017–08738 Filed 4–27–17; 8:45 am] 355(j)(7)), which requires FDA to Furnished by Suppliers) under subpart G (Requirements for Certification and BILLING CODE 4120–01–P publish a list of all approved drugs. Designation and Conditions for FDA publishes this list as part of the Coverage: Organ Procurement ‘‘Approved Drug Products With DEPARTMENT OF HEALTH AND Therapeutic Equivalence Evaluations,’’ Organizations). HUMAN SERVICES Since each OPO has a monopoly on which is generally known as the organ procurement within its designated ‘‘Orange Book.’’ Under FDA regulations, Food and Drug Administration service area (DSA), we must hold OPOs a drug is removed from the list if the to high standards. Collection of this [Docket No. FDA–2017–N–1551] Agency withdraws or suspends information is necessary for us to assess approval of the drug’s NDA or ANDA the effectiveness of each OPO and Determination That DEMEROL for reasons of safety or effectiveness, or determine whether it should continue to (Meperidine Hydrochloride) Injectable if FDA determines that the listed drug be certified as an OPO and designated and Other Drug Products Were Not was withdrawn from sale for reasons of for a particular donation service area by Withdrawn From Sale for Reasons of safety or effectiveness (21 CFR 314.162). the Secretary or replaced by an OPO Safety or Effectiveness Under § 314.161(a) (21 CFR that can more effectively procure organs AGENCY: Food and Drug Administration, 314.161(a)), the Agency must determine within that DSA. Form Number: CMS– HHS. whether a listed drug was withdrawn R–13 (OMB control number: 0938– ACTION: Notice. from sale for reasons of safety or 0688); Frequency: Occasionally; effectiveness: (1) Before an ANDA that Affected Public: Not-for-profit SUMMARY: The Food and Drug refers to that listed drug may be institutions; Number of Respondents: Administration (FDA or Agency) has approved, (2) whenever a listed drug is asabaliauskas on DSK3SPTVN1PROD with NOTICES 58; Total Annual Responses: 58; Total determined that the drug products listed voluntarily withdrawn from sale and Annual Hours: 13,546. (For policy in this document were not withdrawn ANDAs that refer to the listed drug have questions regarding this collection from sale for reasons of safety or been approved, and (3) when a person contact Diane Corning at 410–786– effectiveness. This determination means petitions for such a determination under 8486.) that FDA will not begin procedures to 21 CFR 10.25(a) and 10.30. Section 4. Type of Information Collection withdraw approval of abbreviated new 314.161(d) provides that if FDA Request: Extension of a currently drug applications (ANDAs) that refer to determines that a listed drug was approved collection; Title of these drug products, and it will allow withdrawn from sale for safety or VerDate Sep<11>2014 17:38 Apr 27, 2017 Jkt 241001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\28APN1.SGM 28APN1

19736 Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices effectiveness reasons, the Agency will the withdrawal of approval of the FDA has become aware that the drug initiate proceedings that could result in ANDAs that refer to the listed drug. products listed in the table in this document are no longer being marketed. Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant NDA 005010 ......... DEMEROL ....................... Meperidine Hydrochloride 50 milligrams (mg)/5 milliliter Syrup; Oral ....................... U.S. Pharmaceutical (mL). Holdings II, LLC. NDA 006035 ......... METHERGINE ................. Methylergonovine Maleate 0.2 mg ................................... Tablet; Oral ...................... Edison Therapeutics LLC. NDA 007337 ......... PERCODAN and Aspirin, Oxycodone Hy- 325 mg, 4.5 mg, 0.38 mg; Tablet; Oral ...................... Endo Pharmaceuticals PERCODAN–DEMI. drochloride, Oxycodone and 325 mg, 2.25 mg, 0.19 Inc. Terephthalate. mg. NDA 008720 ......... LEVO–DROMORAN ........ Levorphanol Tartrate ....... 2 mg ...................................... Tablet; Oral ...................... Valeant Pharmaceuticals North America LLC. NDA 008848 ......... PAMINE and PAMINE Methscopolamine Bro- 2.5 mg and 5 mg .................. Tablet; Oral ...................... Fougera Pharmaceuticals FORTE. mide. Inc. NDA 009470 ......... XYLOCAINE VISCOUS ... Lidocaine Hydrochloride .. 2% ......................................... Solution; Oral ................... Fresenius Kabi USA, LLC. NDA 010485 ......... ATARAX ........................... Hydroxyzine Hydro- 10 mg/5 mL ........................... Syrup; Oral ....................... Pfizer Inc. chloride. NDA 010742 ......... COMPAZINE .................... Prochlorperazine Equivalent to (EQ) 5 mg Injectable; Injection .......... GlaxoSmithKline. Edisylate. Base/mL. NDA 012111 ......... MYDRIACYL .................... Tropicamide ..................... 0.5%; 1% .............................. Solution/Drops; Oph- Alcon Laboratories Inc. thalmic. NDA 012248 ......... PLEGINE ......................... Phendimetrazine Tartrate 35 mg .................................... Tablet; Oral ...................... Wyeth Ayerst Labora- tories. NDA 012365 ......... SOMA COMPOUND ........ Aspirin; Carisoprodol ....... 325 mg; 200 mg ................... Tablet; Oral ...................... Meda Pharmaceuticals Inc. NDA 012366 ......... SOMA COMPOUND W/ Aspirin; Carisoprodol; Co- 325 mg; 200 mg; 16 mg ....... Tablet; Oral ...................... Ditto. CODEINE. deine Phosphate. NDA 016012 ......... VIVACTIL ......................... Protriptyline Hydrochloride 5 mg; 10 mg ......................... Tablet; Oral ...................... Teva Women’s Health, Inc. NDA 017352 ......... FASTIN ............................ Phentermine Hydro- 30 mg .................................... Capsule; Oral ................... GlaxoSmithKline. chloride. NDA 017690 ......... IMODIUM ......................... Loperamide Hydrochloride 2 mg ...................................... Capsule; Oral ................... Johnson & Johnson Con- sumer Inc. NDA 017694 ......... IMODIUM ......................... Loperamide Hydrochloride 2 mg ...................................... Capsule; Oral ................... Ditto. NDA 017741 ......... FLORONE ........................ Diflorasone Diacetate ...... 0.05% .................................... Cream; Topical ................ Pharmacia and Upjohn Co. NDA 017802 ......... LO/OVRAL–28 ................. Ethinyl Estradiol; 0.03 mg; 0.3 mg ................... Tablet; Oral-28 ................. Wyeth Pharmaceuticals Norgestrel. Inc. NDA 017857 ......... STADOL ........................... Butorphanol Tartrate ........ 2 mg/mL ................................ Injectable; Injection .......... Delcor Asset Corporation. NDA 017857 ......... STADOL PRESERVA- Butorphanol Tartrate ........ 1 mg/mL; 2 mg/mL ............... Injectable; Injection .......... Ditto. TIVE FREE. NDA 018342 ......... WELLCOVORIN .............. Leucovorin Calcium ......... EQ 5 mg Base; EQ 25 mg Tablet; Oral ...................... GlaxoSmithKline. Base. NDA 018353 ......... FLAGYL I.V. ..................... Metronidazole Hydro- EQ 500 mg Base/Vial ........... Injectable; Injection .......... G.D. Searle LLC, a sub- chloride. sidiary of Pfizer Inc. NDA 018733 ......... TALWIN NX ..................... Naloxone Hydrochloride; EQ 0.5 mg Base; EQ 50 mg Tablet; Oral ...................... Sanofi-Aventis U.S. LLC. Pentazocine Hydro- Base. chloride. NDA 019488 ......... CARDENE ....................... Nicardipine Hydrochloride 20 mg; 30 mg ....................... Capsule; Oral ................... Chiesi USA, Inc. NDA 019578 ......... MEFLOQUINE HYDRO- Mefloquine Hydrochloride 250 mg .................................. Tablet; Oral ...................... U.S. Army Walter Reed CHLORIDE. Army Institute Re- search. NDA 019591 ......... LARIAM ............................ Mefloquine Hydrochloride 250 mg .................................. Tablet; Oral ...................... Hoffmann-La Roche Inc. NDA 019735 ......... FLOXIN ............................ Ofloxacin .......................... 200 mg; 300 mg; 400 mg ..... Tablet; Oral ...................... Janssen Pharmaceuticals, Inc. NDA 019890 ......... STADOL ........................... Butorphanol Tartrate ........ 1 mg/Spray ........................... Spray, Metered; Nasal ..... Bristol-Myers Squibb Co. NDA 020142 ......... CATAFLAM ...................... Diclofenac Potassium ...... 50 mg .................................... Tablet; Oral ...................... Novartis Pharmaceuticals Corp. NDA 020254 ......... VOLTAREN–XR ............... Diclofenac Sodium ........... 100 mg .................................. Extended-Release Tablet; Ditto. Oral. NDA 020312 ......... UNIVASC ......................... Moexipril Hydrochloride ... 7.5 mg; 15 mg ...................... Tablet; Oral ...................... UCB, Inc. NDA 020346 ......... ZYRTEC ........................... Cetirizine Hydrochloride ... 5 mg/5 mL ............................. Syrup; Oral ....................... Johnson & Johnson Con- sumer Inc. NDA 020584 ......... LODINE XL ...................... Etodolac ........................... 400 mg; 500 mg; 600 mg ..... Extended-Release Tablet; Wyeth Pharmaceuticals Oral. Inc. NDA 020625 ......... ALLEGRA ........................ Fexofenadine Hydro- 60 mg .................................... Capsule; Oral ................... Sanofi-Aventis U.S. LLC. chloride. NDA 020729 ......... UNIRETIC ........................ Hydro chlorothiazide; 12.5 mg/7.5 mg; 12.5 mg/15 Tablet; Oral ...................... UCB, Inc. Moexipril Hydrochloride. mg; 25 mg/15 mg. NDA 021066 ......... ZADITOR ......................... Ketotifen Fumarate .......... EQ 0.025% Base .................. Solution/Drops; Oph- Alcon Pharmaceuticals, thalmic. Ltd. asabaliauskas on DSK3SPTVN1PROD with NOTICES NDA 021224 ......... RAZADYNE ..................... Galantamine 4 mg/mL ................................ Solution; Oral ................... Janssen Pharmaceuticals, Hydrobromide. Inc. NDA 021378 ......... COMBUNOX .................... Ibuprofen; Oxycodone Hy- 400 mg; 5 mg ....................... Tablet; Oral ...................... Forest Laboratories, Inc. drochloride. NDA 021473 ......... CIPRO XR ....................... Ciprofloxacin; 212.6 mg; EQ 287.5 mg Extended-Release Tablet; Bayer HealthCare Phar- Ciprofloxacin Hydro- Base; 425.2 mg; EQ 574.9 Oral. maceuticals, Inc. chloride. mg Base. NDA 021606 ......... ZEMPLAR ........................ Paricalcitol ........................ 4 micrograms (mcg) .............. Capsule; Oral ................... AbbVie Inc. NDA 021729 ......... ABILIFY ............................ Aripiprazole ...................... 10 mg and 15 mg ................. Tablet, Orally Disinte- Otsuka Pharmaceutical grating; Oral. Co., Ltd. VerDate Sep<11>2014 17:38 Apr 27, 2017 Jkt 241001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 E:\FR\FM\28APN1.SGM 28APN1

Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices 19737 Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant NDA 050072 ......... PENBRITIN–S ................. Ampicillin Sodium ............ EQ 125 mg Base/Vial; EQ Injectable; Injection .......... Wyeth Ayerst Labora- 250 mg Base/Vial; EQ 500 tories. mg Base/Vial; EQ 1 gram (g) Base/Vial; EQ 2 g Base/Vial; EQ 4 g Base/ Vial. NDA 050309 ......... POLYCILLIN–N ................ Ampicillin Sodium ............ EQ 125 mg Base/Vial; EQ Injectable; Injection .......... Bristol Laboratories Inc. 250 mg Base/Vial; EQ 500 mg Base/Vial; EQ 1 g Base/Vial; EQ 2 g Base/ Vial. NDA 050674 ......... VANTIN ............................ Cefpodoxime Proxetil ....... EQ 100 mg Base; EQ 200 Tablet; Oral ...................... Pharmacia and Upjohn mg Base. Co. ANDA 064170 ...... CEFAZOLIN SODIUM ..... Cefazolin Sodium ............. EQ 10 g Base/Vial; EQ 20 g Injectable; Injection .......... Fresenius Kabi USA, LLC. Base/Vial. ANDA 075406 ...... OGESTREL 0.5/50–21 .... Ethinyl Estradiol; 0.05 mg; 0.5 mg ................... Tablet; Oral-21 ................. Watson Laboratories, Inc. Norgestrel. ANDA 085106 ...... PERCOCET ..................... Acetaminophen; 325 mg; 5 mg ....................... Tablet; Oral ...................... Vintage Pharmaceuticals Oxycodone Hydro- LLC. chloride. ANDA 089351 ...... ROXICET ......................... Acetaminophen; 325 mg/5 mL; 5 mg/5 mL ..... Solution; Oral ................... West-Ward Pharma- Oxycodone Hydro- ceuticals International chloride. Ltd. ANDA 089456 ...... PERPHENAZINE ............. Perphenazine ................... 8 mg ...................................... Tablet; Oral ...................... ANI Pharmaceuticals, Inc. ANDA 089457 ...... PERPHENAZINE ............. Perphenazine ................... 16 mg .................................... Tablet; Oral ...................... Teva Pharmaceuticals USA. ANDA 089707 ...... PERPHENAZINE ............. Perphenazine ................... 2 mg ...................................... Tablet; Oral ...................... Ditto. ANDA 089708 ...... PERPHENAZINE ............. Perphenazine ................... 4 mg ...................................... Tablet; Oral ...................... Do. FDA has reviewed its records and, DEPARTMENT OF HEALTH AND comments by April 30, 2018. Late, under § 314.161, has determined that HUMAN SERVICES untimely filed comments will not be the drug products listed in this considered. Electronic comments must document were not withdrawn from Food and Drug Administration be submitted on or before April 30, sale for reasons of safety or [Docket No. FDA–2016–N–1114] 2018. The https://www.regulations.gov/ effectiveness. Accordingly, the Agency electronic filing system will accept will continue to list the drug products Pharmaceutical Distribution Supply comments until midnight Eastern Time listed in this document in the Chain Pilot Projects; Reopening of at the end of April 30, 2018. Comments ‘‘Discontinued Drug Product List’’ Comment Period; Request for received by mail/hand delivery/courier section of the Orange Book. The Information (for written/paper submissions) will be considered timely if they are ‘‘Discontinued Drug Product List’’ AGENCY: Food and Drug Administration, postmarked or the delivery service identifies, among other items, drug HHS. acceptance receipt is on or before that products that have been discontinued ACTION: Notice; reopening of comment date. from marketing for reasons other than period; request for information. ADDRESSES: You may submit comments safety or effectiveness. as follows: Approved ANDAs that refer to the SUMMARY: The Food and Drug NDAs and ANDAs listed in this Administration (FDA) is reopening the Electronic Submissions document are unaffected by the comment period for the Request for Submit electronic comments in the discontinued marketing of the products Information that appeared in the following way: subject to those NDAs and ANDAs. Federal Register of April 15, 2016. In • Federal eRulemaking Portal: the Request for Information, FDA https://www.regulations.gov/. Follow Additional ANDAs that refer to these requested comments regarding issues the instructions for submitting products may also be approved by the related to utilizing the product identifier comments. Comments submitted Agency if they comply with relevant for product tracing, improving the legal and regulatory requirements. If electronically, including attachments, to technical capabilities of the supply https://www.regulations.gov/ will be FDA determines that labeling for these chain, and identifying system attributes posted to the docket unchanged. drug products should be revised to meet that are necessary to implement the Because your comment will be made current standards, the Agency will requirements established under the public, you are solely responsible for advise ANDA applicants to submit such Drug Supply Chain Security Act ensuring that your comment does not labeling. (DSCSA). The information gathered include any confidential information This is not a significant regulatory from additional public comments will that you or a third party may not wish action subject to Executive Order 12866, further inform the design and to be posted, such as medical and does not impose any additional development of the pilot project(s) that information, your or anyone else’s asabaliauskas on DSK3SPTVN1PROD with NOTICES burden on regulated entities. FDA establishes under the DSCSA. FDA Social Security number, or confidential is reopening the comment period to business information, such as a Dated: April 24, 2017. receive updated comments and any new manufacturing process. Please note that Anna K. Abram, information. if you include your name, contact Deputy Commissioner for Policy, Planning, DATES: FDA is reopening the comment information, or other information that Legislation, and Analysis. period on the Request for Information identifies you in the body of your [FR Doc. 2017–08582 Filed 4–27–17; 8:45 am] published April 15, 2016 (81 FR 22279). comments, that information will be BILLING CODE 4164–01–P Submit either electronic or written posted on https://www.regulations.gov/. VerDate Sep<11>2014 17:38 Apr 27, 2017 Jkt 241001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\28APN1.SGM 28APN1


Document Created: 2017-04-28 03:03:01
Document Modified: 2017-04-28 03:03:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactStacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, [email protected]
FR Citation82 FR 19735 
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