81 FR 61220 - Determination That AQUAMEPHYTON (Phytonadione) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 81, Issue 172 (September 6, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 172 (September 6, 2016)
| Page Range | 61220-61221 | |
| FR Document | 2016-21227 |
[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)] [Notices] [Pages 61220-61221] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21227] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2526] Determination That AQUAMEPHYTON (Phytonadione) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, 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 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. -------------------------------------------------------------------------------------------------------------------------------------------------------- Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant -------------------------------------------------------------------------------------------------------------------------------------------------------- NDA 012223......................... AQUAMEPHYTON.......... Phytonadione.......... 10 milligram (mg)/ Injectable; Injection Teligent Pharma Inc. milliliter (mL); 1 mg/0.5 mL. NDA 016087......................... VALIUM................ Diazepam.............. 5 mg/mL.............. Injectable; Injection Roche. NDA 017090......................... TOFRANIL-PM........... Imipramine Pamoate.... Equivalent to (EQ) 75 Capsule; Oral........ Mallinckrodt mg HCl; EQ 100 mg Pharmaceuticals. HCl; EQ 125 mg HCl; EQ 150 mg HCl. NDA 017558......................... ROBINUL............... Glycopyrrolate........ 0.2 mg/mL............ Injectable; Injection Eurohealth International Sarl. NDA 017911......................... CLINORIL.............. Sulindac.............. 200 mg............... Tablet; Oral......... Merck. NDA 017962......................... PARLODEL.............. Bromocriptine Mesylate EQ 5 mg base......... Capsule; Oral........ US Pharmaceuticals Holdings I LLC. NDA 018579......................... FUROSEMIDE............ Furosemide............ 10 mg/mL............. Injectable; Injection Luitpold Pharmaceuticals, Inc. NDA 018687......................... NORMODYNE............. Labetalol 100 mg; 200 mg; 300 Tablet; Oral......... Schering-Plough Corp. Hydrochloride. mg; 400 mg. NDA 018731......................... BUSPAR................ Buspirone 5 mg................. Tablet; Oral......... Bristol-Myers Squibb. Hydrochloride. NDA 018776......................... NORCURON.............. Vecuronium Bromide.... 10 mg/vial; 20 mg/ Injectable; for Organon USA Inc. vial. Injection. NDA 019773......................... VENTOLIN.............. Albuterol Sulfate..... EQ 0.083% base....... Solution; Inhalation. GlaxoSmithKline. NDA 019810......................... PRILOSEC.............. Omeprazole............ 10 mg; 20 mg; 40 mg.. Capsule, Delayed- AstraZeneca Release Pellets; Pharmaceuticals LP. Oral. NDA 020059......................... ADENOSCAN............. Adenosine............. 60 mg/20 mL (3 mg/ Solution; I.V. Astellas Pharma US, mL); 90 mg/30 mL (3 Infusion. Inc. mg/mL). NDA 020799......................... FLOXIN OTIC........... Ofloxacin............. 0.3%................. Solution/Drops; Otic. Daiichi-Sankyo. NDA 021045......................... PLAN B................ Levonorgestrel........ 0.75 mg.............. Tablet; Oral......... Teva Branded Pharm. NDA 021214......................... RESCULA............... Unoprostone Isopropyl. 0.15%................ Solution/Drops; Sucampo Ophthalmic. Pharmaceuticals, Inc. NDA 050459......................... AMOXIL................ Amoxicillin........... 250 mg; 500 mg....... Capsule; Oral........ GlaxoSmithKline. [[Page 61221]] NDA 050460......................... AMOXIL................ Amoxicillin........... 125 mg/5mL; 50 mg/mL; for Suspension; Oral. GlaxoSmithKline. 250 mg/5 mL. NDA 050460......................... LAROTID............... Amoxicillin........... 50 mg/mL............. for Suspension; Oral. GlaxoSmithKline. ANDA 072652........................ ALBUTEROL SULFATE..... Albuterol Sulfate..... EQ 0.083% base....... Solution; Inhalation. Mylan Specialty L.P. ANDA 075117........................ ORAPRED............... Prednisolone Sodium EQ 15 mg base/5 mL... Solution; Oral....... Concordia Phosphate. Pharmaceuticals Inc. ANDA 075385........................ BUSPIRONE Buspirone 5 mg; 10 mg; 15 mg... Tablet; Oral......... Teva Pharmaceuticals HYDROCHLORIDE. Hydrochloride. USA, Inc. ANDA 078665........................ LEVONORGESTREL........ Levonorgestrel........ 0.75 mg.............. Tablet; Oral......... Watson Labs. ANDA 087811........................ PHRENILIN............. Acetaminophen; 325 mg; 50 mg........ Tablet; Oral......... Valeant Butalbital. Pharmaceuticals International Inc. ANDA 088825........................ BUTALBITAL, Acetaminophen; 325 mg; 50 mg; 40 mg. Capsule; Oral........ Gilbert Labs. ACETAMINOPHEN AND Butalbital; Caffeine. CAFFEINE. -------------------------------------------------------------------------------------------------------------------------------------------------------- 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. Dated: August 30, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-21227 Filed 9-2-16; 8:45 am] BILLING CODE 4164-01-P
![61220 Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices
Desk Officer for the Administration for refer to the products as long as they FDA publishes this list as part of the
Children and Families. meet relevant legal and regulatory ‘‘Approved Drug Products With
requirements. Therapeutic Equivalence Evaluations,’’
Robert Sargis,
FOR FURTHER INFORMATION CONTACT:
which is generally known as the
Reports Clearance Officer.
Stacy Kane, Center for Drug Evaluation ‘‘Orange Book.’’ Under FDA regulations,
[FR Doc. 2016–21250 Filed 9–2–16; 8:45 am]
and Research, Food and Drug a drug is removed from the list if the
BILLING CODE 4184–01–P
Administration, 10903 New Hampshire Agency withdraws or suspends
Ave., Bldg. 51, Rm. 6207, Silver Spring, approval of the drug’s NDA or ANDA
MD 20993–0002, 301–796–8363, for reasons of safety or effectiveness, or
DEPARTMENT OF HEALTH AND
Stacy.Kane@fda.hhs.gov. if FDA determines that the listed drug
HUMAN SERVICES
was withdrawn from sale for reasons of
SUPPLEMENTARY INFORMATION: In 1984,
Food and Drug Administration safety or effectiveness (21 CFR 314.162).
Congress enacted the Drug Price
[Docket No. FDA–2016–N–2526] Competition and Patent Term Under § 314.161(a) (21 CFR
Restoration Act of 1984 (Pub. L. 98–417) 314.161(a)), the Agency must determine
Determination That AQUAMEPHYTON (the 1984 amendments), which whether a listed drug was withdrawn
(Phytonadione) Injectable and Other authorized the approval of duplicate from sale for reasons of safety or
Drug Products Were Not Withdrawn versions of drug products approved effectiveness: (1) Before an ANDA that
From Sale for Reasons of Safety or under an ANDA procedure. ANDA refers to that listed drug may be
Effectiveness applicants must, with certain approved, (2) whenever a listed drug is
exceptions, show that the drug for voluntarily withdrawn from sale and
AGENCY: Food and Drug Administration, ANDAs that refer to the listed drug have
HHS. which they are seeking approval
contains the same active ingredient in been approved, and (3) when a person
ACTION: Notice. petitions for such a determination under
the same strength and dosage form as
SUMMARY: The Food and Drug the ‘‘listed drug,’’ which is a version of 21 CFR 10.25(a) and 10.30. Section
Administration (FDA or Agency) has the drug that was previously approved. 314.161(d) provides that if FDA
determined that the drug products listed ANDA applicants do not have to repeat determines that a listed drug was
in this document were not withdrawn the extensive clinical testing otherwise withdrawn from sale for safety or
from sale for reasons of safety or necessary to gain approval of a new effectiveness reasons, the Agency will
effectiveness. This determination means drug application (NDA). initiate proceedings that could result in
that FDA will not begin procedures to The 1984 amendments include what the withdrawal of approval of the
withdraw approval of abbreviated new is now section 505(j)(7) of the Federal ANDAs that refer to the listed drug.
drug applications (ANDAs) that refer to Food, Drug, and Cosmetic Act (21 U.S.C. FDA has become aware that the drug
these drug products, and it will allow 355(j)(7)), which requires FDA to products listed in the table in this
FDA to continue to approve ANDAs that publish a list of all approved drugs. document are no longer being marketed.
Active
Application No. Drug name Strength(s) Dosage form/route Applicant
ingredient(s)
NDA 012223 ............... AQUAMEPHYTON ... Phytonadione ............ 10 milligram (mg)/mil- Injectable; Injection ... Teligent Pharma Inc.
liliter (mL); 1 mg/
0.5 mL.
NDA 016087 ............... VALIUM ..................... Diazepam .................. 5 mg/mL .................... Injectable; Injection ... Roche.
NDA 017090 ............... TOFRANIL–PM ......... Imipramine Pamoate Equivalent to (EQ) 75 Capsule; Oral ............ Mallinckrodt Pharma-
mg HCl; EQ 100 ceuticals.
mg HCl; EQ 125
mg HCl; EQ 150
mg HCl.
NDA 017558 ............... ROBINUL .................. Glycopyrrolate ........... 0.2 mg/mL ................. Injectable; Injection ... Eurohealth Inter-
national Sarl.
NDA 017911 ............... CLINORIL ................. Sulindac .................... 200 mg ...................... Tablet; Oral ............... Merck.
NDA 017962 ............... PARLODEL ............... Bromocriptine EQ 5 mg base .......... Capsule; Oral ............ US Pharmaceuticals
Mesylate. Holdings I LLC.
NDA 018579 ............... FUROSEMIDE .......... Furosemide ............... 10 mg/mL .................. Injectable; Injection ... Luitpold Pharma-
ceuticals, Inc.
NDA 018687 ............... NORMODYNE .......... Labetalol Hydro- 100 mg; 200 mg; 300 Tablet; Oral ............... Schering-Plough
chloride. mg; 400 mg. Corp.
NDA 018731 ............... BUSPAR ................... Buspirone Hydro- 5 mg .......................... Tablet; Oral ............... Bristol-Myers Squibb.
chloride.
NDA 018776 ............... NORCURON ............. Vecuronium Bromide 10 mg/vial; 20 mg/vial Injectable; for Injec- Organon USA Inc.
tion.
NDA 019773 ............... VENTOLIN ................ Albuterol Sulfate ....... EQ 0.083% base ...... Solution; Inhalation ... GlaxoSmithKline.
NDA 019810 ............... PRILOSEC ................ Omeprazole .............. 10 mg; 20 mg; 40 mg Capsule, Delayed-Re- AstraZeneca Pharma-
lease Pellets; Oral. ceuticals LP.
mstockstill on DSK3G9T082PROD with NOTICES
NDA 020059 ............... ADENOSCAN ........... Adenosine ................. 60 mg/20 mL (3 mg/ Solution; I.V. Infusion Astellas Pharma US,
mL); 90 mg/30 mL Inc.
(3 mg/mL).
NDA 020799 ............... FLOXIN OTIC ........... Ofloxacin ................... 0.3% .......................... Solution/Drops; Otic .. Daiichi-Sankyo.
NDA 021045 ............... PLAN B ..................... Levonorgestrel .......... 0.75 mg ..................... Tablet; Oral ............... Teva Branded Pharm.
NDA 021214 ............... RESCULA ................. Unoprostone Iso- 0.15% ........................ Solution/Drops; Oph- Sucampo Pharma-
propyl. thalmic. ceuticals, Inc.
NDA 050459 ............... AMOXIL .................... Amoxicillin ................. 250 mg; 500 mg ....... Capsule; Oral ............ GlaxoSmithKline.
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![Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices 61221
Active
Application No. Drug name Strength(s) Dosage form/route Applicant
ingredient(s)
NDA 050460 ............... AMOXIL .................... Amoxicillin ................. 125 mg/5mL; 50 mg/ for Suspension; Oral GlaxoSmithKline.
mL; 250 mg/5 mL.
NDA 050460 ............... LAROTID .................. Amoxicillin ................. 50 mg/mL .................. for Suspension; Oral GlaxoSmithKline.
ANDA 072652 ............ ALBUTEROL SUL- Albuterol Sulfate ....... EQ 0.083% base ...... Solution; Inhalation ... Mylan Specialty L.P.
FATE.
ANDA 075117 ............ ORAPRED ................ Prednisolone Sodium EQ 15 mg base/5 mL Solution; Oral ............ Concordia Pharma-
Phosphate. ceuticals Inc.
ANDA 075385 ............ BUSPIRONE HY- Buspirone Hydro- 5 mg; 10 mg; 15 mg Tablet; Oral ............... Teva Pharma-
DROCHLORIDE. chloride. ceuticals USA, Inc.
ANDA 078665 ............ LEVONORGESTREL Levonorgestrel .......... 0.75 mg ..................... Tablet; Oral ............... Watson Labs.
ANDA 087811 ............ PHRENILIN ............... Acetaminophen; 325 mg; 50 mg ......... Tablet; Oral ............... Valeant Pharma-
Butalbital. ceuticals Inter-
national Inc.
ANDA 088825 ............ BUTALBITAL, ACET- Acetaminophen; 325 mg; 50 mg; 40 Capsule; Oral ............ Gilbert Labs.
AMINOPHEN AND Butalbital; Caffeine. mg.
CAFFEINE.
FDA has reviewed its records and, DEPARTMENT OF HEALTH AND solely responsible for ensuring that your
under § 314.161, has determined that HUMAN SERVICES comment does not include any
the drug products listed in this confidential information that you or a
document were not withdrawn from Food and Drug Administration third party may not wish to be posted,
sale for reasons of safety or [Docket No. FDA–2013–N–1064] such as medical information, your or
effectiveness. Accordingly, the Agency anyone else’s Social Security number, or
will continue to list the drug products Agency Information Collection confidential business information, such
listed in this document in the Activities; Proposed Collection; as a manufacturing process. Please note
‘‘Discontinued Drug Product List’’ Comment Request; Application for that if you include your name, contact
section of the Orange Book. The Participation in the Medical Device information, or other information that
‘‘Discontinued Drug Product List’’ Fellowship Program identifies you in the body of your
identifies, among other items, drug comments, that information will be
AGENCY: Food and Drug Administration, posted on http://www.regulations.gov.
products that have been discontinued HHS. • If you want to submit a comment
from marketing for reasons other than ACTION: Notice. with confidential information that you
safety or effectiveness. do not wish to be made available to the
Approved ANDAs that refer to the SUMMARY: The Food and Drug public, submit the comment as a
NDAs and ANDAs listed in this Administration (FDA) is announcing an written/paper submission and in the
document are unaffected by the opportunity for public comment on the manner detailed (see ‘‘Written/Paper
proposed collection of certain Submissions’’ and ‘‘Instructions’’).
discontinued marketing of the products
information by the Agency. Under the
subject to those NDAs and ANDAs. Written/Paper Submissions
Paperwork Reduction Act of 1995 (the
Additional ANDAs that refer to these
PRA), Federal Agencies are required to Submit written/paper submissions as
products may also be approved by the publish notice in the Federal Register
Agency if they comply with relevant follows:
concerning each proposed collection of • Mail/Hand delivery/Courier (for
legal and regulatory requirements. If information, including each proposed written/paper submissions): Division of
FDA determines that labeling for these extension of an existing collection of Dockets Management (HFA–305), Food
drug products should be revised to meet information, and to allow 60 days for and Drug Administration, 5630 Fishers
current standards, the Agency will public comment in response to the Lane, Rm. 1061, Rockville, MD 20852.
advise ANDA applicants to submit such notice. This notice solicits comments on • For written/paper comments
labeling. the application for participation in the submitted to the Division of Dockets
Dated: August 30, 2016. Medical Device Fellowship Program. Management, FDA will post your
Leslie Kux, DATES: Submit either electronic or comment, as well as any attachments,
Associate Commissioner for Policy.
written comments on the collection of except for information submitted,
information by November 7, 2016. marked and identified, as confidential,
[FR Doc. 2016–21227 Filed 9–2–16; 8:45 am]
ADDRESSES: You may submit comments if submitted as detailed in
BILLING CODE 4164–01–P
as follows: ‘‘Instructions.’’
Instructions: All submissions received
Electronic Submissions must include the Docket No. [FDA–
Submit electronic comments in the 2013–N–1064] for ‘‘Agency Information
following way: Collection Activities; Proposed
• Federal eRulemaking Portal: http:// Collection; Comment Request;
mstockstill on DSK3G9T082PROD with NOTICES
www.regulations.gov. Follow the Application for Participation in the
instructions for submitting comments. Medical Device Fellowship Program.’’
Comments submitted electronically, Received comments will be placed in
including attachments, to http:// the docket and, except for those
www.regulations.gov will be posted to submitted as ‘‘Confidential
the docket unchanged. Because your Submissions,’’ publicly viewable at
comment will be made public, you are http://www.regulations.gov or at the
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Document Created: 2018-02-09 12:04:20
Document Modified: 2018-02-09 12:04:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363, [email protected] | |
| FR Citation | 81 FR 61220 |
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