Determination That AQUAMEPHYTON (Phytonadione) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 61220-61221 [2016-21227]

Download as PDF 61220 Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2016–21250 Filed 9–2–16; 8:45 am] BILLING CODE 4184–01–P 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[Docket No. FDA–2016–N–2526] Determination That AQUAMEPHYTON (Phytonadione) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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: refer to the products as long as they meet relevant legal and regulatory requirements. Notice. The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 SUMMARY: 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, Stacy.Kane@fda.hhs.gov. 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 § 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. Drug name Active ingredient(s) Strength(s) Dosage form/route NDA 012223 ............... AQUAMEPHYTON ... Phytonadione ............ Teligent Pharma Inc. VALIUM ..................... TOFRANIL–PM ......... Diazepam .................. Imipramine Pamoate Injectable; Injection ... Capsule; Oral ............ Roche. Mallinckrodt Pharmaceuticals. NDA 017558 ............... ROBINUL .................. Glycopyrrolate ........... 10 milligram (mg)/milliliter (mL); 1 mg/ 0.5 mL. 5 mg/mL .................... Equivalent to (EQ) 75 mg HCl; EQ 100 mg HCl; EQ 125 mg HCl; EQ 150 mg HCl. 0.2 mg/mL ................. Injectable; Injection ... NDA 016087 ............... NDA 017090 ............... Injectable; Injection ... NDA 017911 ............... NDA 017962 ............... CLINORIL ................. PARLODEL ............... Tablet; Oral ............... Capsule; Oral ............ FUROSEMIDE .......... Sulindac .................... Bromocriptine Mesylate. Furosemide ............... 200 mg ...................... EQ 5 mg base .......... NDA 018579 ............... 10 mg/mL .................. Injectable; Injection ... NDA 018687 ............... NORMODYNE .......... BUSPAR ................... 100 mg; 200 mg; 300 mg; 400 mg. 5 mg .......................... Eurohealth International Sarl. Merck. US Pharmaceuticals Holdings I LLC. Luitpold Pharmaceuticals, Inc. Schering-Plough Corp. Bristol-Myers Squibb. NDA 018776 ............... NORCURON ............. Labetalol Hydrochloride. Buspirone Hydrochloride. Vecuronium Bromide Tablet; Oral ............... NDA 018731 ............... 10 mg/vial; 20 mg/vial NDA 019773 ............... NDA 019810 ............... mstockstill on DSK3G9T082PROD with NOTICES Application No. VENTOLIN ................ PRILOSEC ................ Albuterol Sulfate ....... Omeprazole .............. EQ 0.083% base ...... 10 mg; 20 mg; 40 mg NDA 020059 ............... ADENOSCAN ........... Adenosine ................. NDA 020799 ............... NDA 021045 ............... NDA 021214 ............... FLOXIN OTIC ........... PLAN B ..................... RESCULA ................. NDA 050459 ............... AMOXIL .................... Ofloxacin ................... Levonorgestrel .......... Unoprostone Isopropyl. Amoxicillin ................. 60 mg/20 mL (3 mg/ mL); 90 mg/30 mL (3 mg/mL). 0.3% .......................... 0.75 mg ..................... 0.15% ........................ VerDate Sep<11>2014 17:04 Sep 02, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 250 mg; 500 mg ....... Sfmt 4703 Tablet; Oral ............... Injectable; for Injection. Solution; Inhalation ... Capsule, Delayed-Release Pellets; Oral. Solution; I.V. Infusion Solution/Drops; Otic .. Tablet; Oral ............... Solution/Drops; Ophthalmic. Capsule; Oral ............ E:\FR\FM\06SEN1.SGM 06SEN1 Applicant Organon USA Inc. GlaxoSmithKline. AstraZeneca Pharmaceuticals LP. Astellas Pharma US, Inc. Daiichi-Sankyo. Teva Branded Pharm. Sucampo Pharmaceuticals, Inc. GlaxoSmithKline. 61221 Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices Application No. Drug name Active ingredient(s) Strength(s) NDA 050460 ............... AMOXIL .................... Amoxicillin ................. for Suspension; Oral GlaxoSmithKline. NDA 050460 ............... ANDA 072652 ............ LAROTID .................. ALBUTEROL SULFATE. ORAPRED ................ Amoxicillin ................. Albuterol Sulfate ....... 125 mg/5mL; 50 mg/ mL; 250 mg/5 mL. 50 mg/mL .................. EQ 0.083% base ...... for Suspension; Oral Solution; Inhalation ... GlaxoSmithKline. Mylan Specialty L.P. Prednisolone Sodium Phosphate. Buspirone Hydrochloride. Levonorgestrel .......... Acetaminophen; Butalbital. EQ 15 mg base/5 mL Solution; Oral ............ 5 mg; 10 mg; 15 mg Tablet; Oral ............... 0.75 mg ..................... 325 mg; 50 mg ......... Tablet; Oral ............... Tablet; Oral ............... Acetaminophen; Butalbital; Caffeine. 325 mg; 50 mg; 40 mg. Capsule; Oral ............ Concordia Pharmaceuticals Inc. Teva Pharmaceuticals USA, Inc. Watson Labs. Valeant Pharmaceuticals International Inc. Gilbert Labs. ANDA 075117 ............ ANDA 075385 ............ ANDA 078665 ............ ANDA 087811 ............ ANDA 088825 ............ BUSPIRONE HYDROCHLORIDE. LEVONORGESTREL PHRENILIN ............... BUTALBITAL, ACETAMINOPHEN AND CAFFEINE. FDA has reviewed its records and, under § 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1064] Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the application for participation in the Medical Device Fellowship Program. DATES: Submit either electronic or written comments on the collection of information by November 7, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: mstockstill on DSK3G9T082PROD with NOTICES Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are VerDate Sep<11>2014 17:04 Sep 02, 2016 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Dosage form/route Applicant solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. [FDA– 2013–N–1064] for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the E:\FR\FM\06SEN1.SGM 06SEN1

Agencies

[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)]
[Notices]
[Pages 61220-61221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21227]


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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, 
Stacy.Kane@fda.hhs.gov.

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