81 FR 81780 - Determination That BENEMID (Probenecid) Tablet and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 223 (November 18, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 223 (November 18, 2016)
| Page Range | 81780-81782 | |
| FR Document | 2016-27855 |
[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)] [Notices] [Pages 81780-81782] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27855] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-3680] Determination That BENEMID (Probenecid) Tablet and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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Administration (FDA or Agency) has [[Page 81781]] determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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. ---------------------------------------------------------------------------------------------------------------- Active Dosage form/ Application No. Drug name ingredient(s) Strength(s) route Applicant ---------------------------------------------------------------------------------------------------------------- NDA 007898.......... BENEMID.......... Probenecid....... 500 milligrams Tablet; Oral.... Merck and Co., (mg). Inc. NDA 008048.......... XYLOCAINE........ Lidocaine........ 5%.............. Ointment; AstraZeneca Topical. Pharmaceuticals LP. NDA 011111.......... VISTARIL......... Hydroxyzine 25 mg/milliliter Injectable; Pfizer Inc. Hydrochloride (mL); 50 mg/mL. Injection. (HCl). NDA 012209.......... FLUOROURACIL..... Fluorouracil..... 500 mg/10 mL (50 Injectable; Spectrum mg/mL). Injection. Pharmaceuticals , Inc. NDA 013220.......... PERIACTIN........ Cyproheptadine 2 mg/5 mL....... Syrup; Oral..... Merck and Co., HCl. Inc. NDA 017534.......... FIORINAL......... Aspirin; 325 mg; 50 mg; Tablet; Oral.... Allergan Sales, Butalbital; 40 mg. LLC. Caffeine. NDA 017577.......... DITROPAN......... Oxybutynin 5 mg............ Tablet; Oral.... Ortho-McNeil- Chloride. Janssen Pharmaceuticals , Inc. NDA 017781.......... DIPROSONE........ Betamethasone Equivalent to Lotion; Topical. Schering Corp. Dipropionate. (EQ) 0.05% Base. NDA 018211.......... DITROPAN......... Oxybutynin 5 mg/5 mL....... Syrup; Oral..... Ortho-McNeil- Chloride. Janssen Pharmaceuticals , Inc. NDA 018586.......... TOPICORT......... Desoximetasone... 0.05%........... Gel; Topical.... Taro Pharmaceuticals U.S.A., Inc. NDA 018631.......... TRENTAL.......... Pentoxifylline... 400 mg.......... Extended-Release U.S. Tablet; Oral. Pharmaceutical Holdings II, LLC. NDA 019155.......... LAC-HYDRIN....... Ammonium Lactate. EQ 12% Base..... Lotion; Topical. Ranbaxy Laboratories Inc. NDA 019323.......... TEMOVATE......... Clobetasol 0.05%........... Ointment; Fougera Propionate. Topical. Pharmaceuticals Inc. NDA 019778.......... PRINZIDE......... Hydrochlorothiazi 12.5 mg/10 mg; Tablet; Oral.... Merck Sharp & de; Lisinopril. 12.5mg/20mg. Dohme Corp., Subsidiary of Merck & Co., Inc. NDA 019842.......... MOTRIN........... Ibuprofen........ 100 mg/5 mL..... Suspension; Oral McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. NDA 019915.......... MONOPRIL......... Fosinopril Sodium 10 mg; 20 mg; 40 Tablet; Oral.... Bristol-Myers mg. Squibb Co. NDA 020343.......... PRIMACOR IN Milrinone Lactate EQ 10 mg Base/ Injectable; Sanofi-Aventis DEXTROSE 5% IN 100 mL; EQ 15 Injection. U.S. LLC. PLASTIC mg Base/100 mL; CONTAINER. EQ 20 mg Base/ 100 mL; EQ 40 mg Base/200 mL. NDA 020508.......... LAC-HYDRIN....... Ammonium Lactate. EQ 12% Base..... Cream; Topical.. Ranbaxy Laboratories, Inc. NDA 020635.......... LEVAQUIN IN Levofloxacin..... EQ 250 mg/50 mL Injectable; Janssen DEXTROSE 5% IN (EQ 5 mg/mL); Injection. Pharmaceuticals PLASTIC EQ 500 mg/100 , Inc. CONTAINER. mL (EQ 5 mg/ mL); EQ 750 mg/ 150 mL (EQ 5 mg/ mL). NDA 020863.......... PLETAL........... Cilostazol....... 50 mg; 100 mg... Tablet; Oral.... Otsuka Pharmaceutical Co., Ltd. NDA 20950........... DUONEB........... Albuterol EQ 0.083% Base; Solution; Mylan Specialty, Sulfate; 0.017%. Inhalation. L.P. Ipratropium Bromide. NDA 21460........... METAGLIP......... Glipizide; 2.5 mg/250 mg; Tablet; Oral.... Bristol-Myers Metformin HCl. 2.5 mg/500 mg; Squibb Co. 5 mg/500 mg. NDA 021759.......... ELOXATIN......... Oxaliplatin...... 200 mg/40 mL (5 Injectable; Sanofi-Aventis mg/mL). Intravenous U.S. LLC. (Infusion). NDA 050442.......... VIBRAMYCIN....... Doxycycline EQ 100 mg Base/ Injectable; Pfizer Inc. Hyclate. Vial; EQ 200 mg Injection. Base/Vial. [[Page 81782]] NDA 050624.......... ROCEPHIN W/ Ceftriaxone EQ 10 mg Base/ Injectable; Hoffmann-La DEXTROSE IN Sodium. mL; EQ 20 mg Injection. Roche, Inc. PLASTIC Base/mL; EQ 40 CONTAINER. mg Base/mL. NDA 050739.......... OMNICEF.......... Cefdinir......... 300 mg.......... Capsule; Oral... AbbVie Inc. NDA 050749.......... OMNICEF.......... Cefdinir......... 125 mg/5 mL; 250 For Suspension; AbbVie Inc. mg/5 mL. Oral. ANDA 060003......... V-CILLIN K....... Penicillin V EQ 125 mg Base; Tablet; Oral.... Eli Lilly and Potassium. EQ 250 mg Base; Company. EQ 500 mg Base. ANDA 060463......... GARAMYCIN........ Gentamicin EQ 0.1% Base.... Ointment; Schering-Plough Sulfate. Topical. Corp. ANDA 086833......... CYPROHEPTADINE Cyproheptadine 2 mg/5mL........ Syrup; Oral..... Actavis Mid HYDROCHLORIDE. HCl. Atlantic LLC. ANDA 088877......... BENZTROPINE Benztropine 0.5 mg.......... Tablet; Oral.... Lannett MESYLATE. Mesylate. Holdings, Inc. ANDA 088894......... BENZTROPINE Benztropine 1 mg............ Tablet; Oral.... Lannett MESYLATE. Mesylate. Holdings, Inc. ANDA 088895......... BENZTROPINE Benztropine 2 mg............ Tablet; Oral.... Lannett MESYLATE. Mesylate. Holdings, Inc. ---------------------------------------------------------------------------------------------------------------- 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: November 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-27855 Filed 11-17-16; 8:45 am] BILLING CODE 4164-01-P
![81780 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
Written/Paper Submissions regulatoryinformation/dockets/ This guidance is being issued
default.htm. consistent with FDA’s good guidance
Submit written/paper submissions as Docket: For access to the docket to practices regulation (21 CFR 10.115).
follows: read background documents or the FDA is issuing this guidance for
• Mail/Hand delivery/Courier (for electronic and written/paper comments immediate implementation in
written/paper submissions): Division of received, go to http:// accordance with 21 CFR 10.115(g)(2)
Dockets Management (HFA–305), Food www.regulations.gov and insert the without initially seeking prior comment
and Drug Administration, 5630 Fishers docket number, found in brackets in the because the Agency has determined that
Lane, Rm. 1061, Rockville, MD 20852. heading of this document, into the prior public participation is not
• For written/paper comments ‘‘Search’’ box and follow the prompts appropriate. This guidance recommends
submitted to the Division of Dockets and/or go to the Division of Dockets a less burdensome policy that is
Management, FDA will post your Management, 5630 Fishers Lane, Rm. consistent with the public health. The
comment, as well as any attachments, 1061, Rockville, MD 20852. guidance represents the current thinking
except for information submitted, Submit written requests for single of FDA on ‘‘Revised Recommendations
marked and identified, as confidential, copies of the guidance to the Office of for Determining Eligibility of Donors of
if submitted as detailed in Communication, Outreach and Human Cells, Tissues, and Cellular and
‘‘Instructions.’’ Development, Center for Biologics Tissue-Based Products Who Have
Instructions: All submissions received Evaluation and Research (CBER), Food Received Human-Derived Clotting
must include the Docket No. FDA– and Drug Administration, 10903 New Factor Concentrates.’’ It does not
2016–D–3750 for ‘‘Revised Hampshire Ave., Bldg. 71, Rm. 3128, establish any rights for any person and
Recommendations for Determining Silver Spring, MD 20993–0002. Send is not binding on FDA or the public.
Eligibility of Donors of Human Cells, one self-addressed adhesive label to You can use an alternative approach if
Tissues, and Cellular and Tissue-Based assist the office in processing your it satisfies the requirements of the
Products Who Have Received Human- requests. The guidance may also be applicable statutes and regulations.
Derived Clotting Factor Concentrates; obtained by mail by calling CBER at 1–
II. Paperwork Reduction Act of 1995
Guidance for Industry.’’ Received 800–835–4709 or 240–402–8010. See
comments will be placed in the docket the SUPPLEMENTARY INFORMATION section This guidance refers to previously
and, except for those submitted as for electronic access to the guidance approved collections of information
‘‘Confidential Submissions,’’ publicly document. found in FDA regulations. These
viewable at http://www.regulations.gov collections of information are subject to
FOR FURTHER INFORMATION CONTACT:
or at the Division of Dockets review by the Office of Management and
Melissa Segal, Center for Biologics
Management between 9 a.m. and 4 p.m., Budget (OMB) under the Paperwork
Evaluation and Research, Food and
Monday through Friday. Reduction Act of 1995 (44 U.S.C. 3501–
Drug Administration, 10903 New
3520). The collections of information in
• Confidential Submissions—To Hampshire Ave., Bldg. 71, Rm. 7301,
21 CFR 1271.47 have been approved
submit a comment with confidential Silver Spring, MD 20993–0002, 240–
under OMB control number 0910–0543.
information that you do not wish to be 402–7911.
made publicly available, submit your SUPPLEMENTARY INFORMATION: III. Electronic Access
comments only as a written/paper Persons with access to the Internet
submission. You should submit two I. Background
may obtain the guidance at either http://
copies total. One copy will include the FDA is announcing the availability of www.fda.gov/BiologicsBloodVaccines/
information you claim to be confidential a document entitled ‘‘Revised GuidanceComplianceRegulatory
with a heading or cover note that states Recommendations for Determining Information/Guidances/default.htm or
‘‘THIS DOCUMENT CONTAINS Eligibility of Donors of Human Cells, http://www.regulations.gov.
CONFIDENTIAL INFORMATION.’’ The Tissues, and Cellular and Tissue-Based
Dated: November 14, 2016.
Agency will review this copy, including Products Who Have Received Human-
the claimed confidential information, in Derived Clotting Factor Concentrates; Leslie Kux,
its consideration of comments. The Guidance for Industry.’’ The guidance Associate Commissioner for Policy.
second copy, which will have the document provides establishments that [FR Doc. 2016–27768 Filed 11–17–16; 8:45 am]
claimed confidential information make DE determinations for donors of BILLING CODE 4164–01–P
redacted/blacked out, will be available HCT/Ps with information on infectious
for public viewing and posted on http:// disease risks related to receipt of
www.regulations.gov. Submit both HDCFCs. The guidance explains that DEPARTMENT OF HEALTH AND
copies to the Division of Dockets FDA no longer considers FDA licensed HUMAN SERVICES
Management. If you do not wish your HDCFCs as a risk factor for HIV, HBV,
Food and Drug Administration
name and contact information to be or HCV. As such, receipt of FDA
made publicly available, you can licensed HDCFCs, or sex with a person [Docket No. FDA–2016–N–3680]
provide this information on the cover who has received FDA licensed
sheet and not in the body of your HDCFCs, should not be considered a Determination That BENEMID
comments and you must identify this risk factor when determining eligibility (Probenecid) Tablet and Other Drug
information as ‘‘confidential.’’ Any of a donor of HCT/Ps. The Products Were Not Withdrawn From
information marked as ‘‘confidential’’ recommendations in the guidance Sale for Reasons of Safety or
mstockstill on DSK3G9T082PROD with NOTICES
will not be disclosed except in supersede the recommendations Effectiveness
accordance with 21 CFR 10.20 and other contained in section IV.E.3. of the AGENCY: Food and Drug Administration,
applicable disclosure law. For more guidance entitled ‘‘Eligibility HHS.
information about FDA’s posting of Determination for Donors of Human ACTION: Notice.
comments to public dockets, see 80 FR Cells, Tissues, and Cellular and Tissue-
56469, September 18, 2015, or access Based Products (HCT/Ps); Guidance for SUMMARY: The Food and Drug
the information at: http://www.fda.gov/ Industry’’ dated August 2007. Administration (FDA or Agency) has
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![81782 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant
NDA 050624 ....... ROCEPHIN W/DEX- Ceftriaxone Sodium ......... EQ 10 mg Base/mL; EQ 20 Injectable; Injection .......... Hoffmann-La Roche, Inc.
TROSE IN PLASTIC mg Base/mL; EQ 40 mg
CONTAINER. Base/mL.
NDA 050739 ....... OMNICEF ......................... Cefdinir ............................. 300 mg .................................. Capsule; Oral ................... AbbVie Inc.
NDA 050749 ....... OMNICEF ......................... Cefdinir ............................. 125 mg/5 mL; 250 mg/5 mL For Suspension; Oral ....... AbbVie Inc.
ANDA 060003 ..... V–CILLIN K ...................... Penicillin V Potassium ..... EQ 125 mg Base; EQ 250 Tablet; Oral ...................... Eli Lilly and Company.
mg Base; EQ 500 mg
Base.
ANDA 060463 ..... GARAMYCIN ................... Gentamicin Sulfate ........... EQ 0.1% Base ...................... Ointment; Topical ............. Schering-Plough Corp.
ANDA 086833 ..... CYPROHEPTADINE HY- Cyproheptadine HCl ......... 2 mg/5mL .............................. Syrup; Oral ....................... Actavis Mid Atlantic LLC.
DROCHLORIDE.
ANDA 088877 ..... BENZTROPINE Benztropine Mesylate ...... 0.5 mg ................................... Tablet; Oral ...................... Lannett Holdings, Inc.
MESYLATE.
ANDA 088894 ..... BENZTROPINE Benztropine Mesylate ...... 1 mg ...................................... Tablet; Oral ...................... Lannett Holdings, Inc.
MESYLATE.
ANDA 088895 ..... BENZTROPINE Benztropine Mesylate ...... 2 mg ...................................... Tablet; Oral ...................... Lannett Holdings, Inc.
MESYLATE.
FDA has reviewed its records and, DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
under § 314.161, has determined that HUMAN SERVICES confidential business information, such
the drug products listed in this as a manufacturing process. Please note
document were not withdrawn from Food and Drug Administration that if you include your name, contact
sale for reasons of safety or [Docket Nos. FDA–2015–M–3249, FDA– information, or other information that
effectiveness. Accordingly, the Agency 2015–M–3251, FDA–2015–M–3253, FDA– identifies you in the body of your
will continue to list the drug products 2015–M–4130, FDA 2015–M–3254, FDA– comments, that information will be
listed in this document in the 2016–M–2210, FDA–2014–M–0740, FDA– posted on http://www.regulations.gov.
‘‘Discontinued Drug Product List’’
2016–M–1072, FDA–2014–M–2304, FDA– • If you want to submit a comment
2014–M–2305, FDA–2015–M–2100, FDA– with confidential information that you
section of the Orange Book. The 2015–M–3255, FDA–2015–M–4981] do not wish to be made available to the
‘‘Discontinued Drug Product List’’
Medical Devices Regulated by the public submit the comment as a written/
identifies, among other items, drug
Center for Biologics Evaluation and paper submission and in the manner
products that have been discontinued
Research; Availability of Safety and detailed (see ‘‘Written/Paper
from marketing for reasons other than Submissions’’ and ‘‘Instructions’’).
safety or effectiveness. Effectiveness Summaries for
Premarket Approval Applications Written/Paper Submissions
Approved ANDAs that refer to the
NDAs and ANDAs listed in this AGENCY: Food and Drug Administration, Submit written/paper submissions as
document are unaffected by the HHS. follows:
discontinued marketing of the products ACTION: Notice. • Mail/Hand delivery/Courier (for
subject to those NDAs and ANDAs. written/paper submissions): Division of
SUMMARY: The Food and Drug Dockets Management (HFA–305), Food
Additional ANDAs that refer to these
Administration (FDA) is publishing a and Drug Administration, 5630 Fishers
products may also be approved by the
list of premarket approval applications Lane, Rm. 1061, Rockville, MD 20852.
Agency if they comply with relevant (PMAs) that have been approved by the • For written/paper comments
legal and regulatory requirements. If Center for Biologics Evaluation and submitted to the Division of Dockets
FDA determines that labeling for these Research (CBER). This list is intended to Management, FDA will post your
drug products should be revised to meet inform the public of the availability of comment, as well as any attachments,
current standards, the Agency will safety and effectiveness summaries of except for information submitted,
advise ANDA applicants to submit such approved PMAs through the Internet marked and identified, as confidential,
labeling. and the Agency’s Division of Dockets if submitted as detailed in
Dated: November 14, 2016. Management. ‘‘Instructions.’’
Leslie Kux, ADDRESSES: You may submit comments Instructions: All submissions received
as follows: must include the Docket Nos. FDA–
Associate Commissioner for Policy.
2015–M–3249, FDA–2015–M–3251,
[FR Doc. 2016–27855 Filed 11–17–16; 8:45 am] Electronic Submissions FDA–2015–M–3253, FDA–2015–M–
BILLING CODE 4164–01–P Submit electronic comments in the 4130, 2015–M–3254, FDA–2016–M–
following way: 2210, FDA–2014–M–0740, FDA–2016–
• Federal eRulemaking Portal: http:// M–1072, FDA–2014–M–2304, FDA–
www.regulations.gov. Follow the 2014–M–2305, FDA–2015–M–2100,
instructions for submitting comments. FDA–2015–M–3255, FDA–2015–M–
Comments submitted electronically, 4981 for ‘‘Medical Devices Regulated by
including attachments, to http:// the Center for Biologics Evaluation and
www.regulations.gov will be posted to Research; Availability of Safety and
mstockstill on DSK3G9T082PROD with NOTICES
the docket unchanged. Because your Effectiveness Summaries for Premarket
comment will be made public, you are Approval Applications.’’ Received
solely responsible for ensuring that your comments will be placed in the docket
comment does not include any and, except for those submitted as
confidential information that you or a ‘‘Confidential Submissions,’’ publicly
third party may not wish to be posted, viewable at http://www.regulations.gov
such as medical information, your or or at the Division of Dockets
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Document Created: 2018-02-14 08:31:38
Document Modified: 2018-02-14 08:31:38
| 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 81780 |
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