Determination That KENALOG (Triamcinolone Acetonide) Ointment, 0.025% and 0.1%, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 52113-52114 [2019-21201]

Download as PDF 52113 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Notices disability, please contact AnnMarie Williams, at AnnMarie.Williams@fda.hhs.gov or 301–796–5966 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 25, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–21248 Filed 9–30–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–4329] Determination That KENALOG (Triamcinolone Acetonide) Ointment, 0.025% and 0.1%, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to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 are no longer being marketed. Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route NDA 011600 .......... KENALOG ...................... Triamcinolone Acetonide .. 0.025%; 0.1% .................... Ointment; Topical .............. NDA 012827 .......... NDA 018029 .......... ROBINUL ........................ ROBINUL FORTE .......... RITALIN–SR ................... 1 milligram (mg) ................ 2 mg .................................. 20 mg ................................ NDA 018164 .......... ANAPROX ...................... Glycopyrrolate ................... Glycopyrrolate ................... Methylphenidate Hydrochloride. Naproxen Sodium ............. Tablet; Oral ....................... Tablet; Oral. Extended-Release Tablet; Oral. Tablet; Oral ....................... NDA 018405 .......... AYGESTIN ..................... Norethindrone Acetate ...... NDA 018452 .......... SEPTRA ......................... NDA 018703 .......... ZANTAC 150 .................. ZANTAC 300 .................. TUSSIONEX PENNKINETIC. Sulfamethoxazole; Trimethoprim. Ranitidine Hydrochloride ... Ranitidine Hydrochloride ... Chlorpheniramine Polistirex; Hydrocodone Polistirex. Equivalent to (EQ) 250 mg Base. 5 mg .................................. ADENOCARD ................. REMERON ..................... MAVIK ............................ MAXALT ......................... Betaxolol Hydrochloride .... Ciprofloxacin Hydrochloride. Adenosine ......................... Mirtazapine ........................ Trandolapril ....................... Rizatriptan Benzoate ......... 16 mg/milliliter (mL); 80 mg/mL. EQ 150 mg Base .............. EQ 300 mg Base .............. EQ 8 mg Chlorpheniramine Maleate/5 mL; EQ 10 mg Hydrocodone Bitartrate/5 mL. 10 mg; 20 mg .................... EQ 100 mg Base; EQ 750 mg Base. 3 mg/mL ............................ 45 mg ................................ 1 mg; 2 mg; 4 mg ............. EQ 5 mg Base .................. NDA 020865 .......... MAXALT–MLT ................ Rizatriptan Benzoate ......... EQ 5 mg Base .................. NDA 020945 .......... NDA 021131 .......... NORVIR .......................... ZYVOX ........................... Ritonavir ............................ Linezolid ............................ 100 mg .............................. 400 mg/200 mL (2 mg/mL) NDA 019111 .......... jbell on DSK3GLQ082PROD with NOTICES 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. 6236, 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). NDA 019507 .......... NDA 019537 .......... KERLONE ...................... CIPRO ............................ NDA NDA NDA NDA .......... .......... .......... .......... 019937 020415 020528 020864 VerDate Sep<11>2014 18:10 Sep 30, 2019 Jkt 250001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Tablet; Oral ....................... Injectable; Injection ........... Tablet; Oral ....................... Tablet; Oral. Extended-Release Suspension; Oral. Tablets; Oral ..................... Tablet; Oral ....................... Injectable; Injection ........... Tablet; Oral ....................... Tablet; Oral ....................... Tablet; Oral ....................... Orally Disintegrating Tablet; Oral. Capsule; Oral .................... Injectable; Injection ........... E:\FR\FM\01OCN1.SGM 01OCN1 Applicant Mylan Pharmaceuticals, Inc. Casper Pharma LLC. Novartis Pharmaceuticals, Corp. ATNAHS Pharma U.S., Ltd. Teva Branded Pharmaceutical Products R&D, Inc. Monarch Pharmaceuticals, Inc. GlaxoSmithKline. UCB, Inc. Sanofi-Aventis U.S. LLC. Bayer Healthcare Pharmaceuticals, Inc. Astellas Pharma U.S., Inc. Organon USA, Inc. AbbVie, Inc. Merck Sharp & Dohme Corp. Do. AbbVie, Inc. Pharmacia & Upjohn Co. 52114 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Notices Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route NDA 021381 .......... Epinephrine; Lidocaine Hydrochloride. Ribavirin ............................ Amiodarone Hydrochloride Cefuroxime Axetil .............. NDA 050730 .......... NDA 050746 .......... NDA 205103 .......... ZITHROMAX .................. BACTROBAN ................. YOSPRALA .................... Azithromycin ...................... Mupirocin Calcium ............ Aspirin; Omeprazole ......... 0.01 mg/mL/2%; 0.02 mg/ mL/2%. 200 mg; 400 mg ................ 50 mg/mL .......................... EQ 125 mg Base; EQ 250 mg Base; EQ 500 mg Base. EQ 600 mg Base .............. EQ 2% Base ..................... 81 mg/40 mg; 325 mg/40 mg. Injectable; Injection ........... NDA 021511 .......... NDA 022325 .......... NDA 050605 .......... XYLOCAINE DENTAL WITH EPINEPHRINE. COPEGUS ...................... NEXTERONE ................. CEFTIN ........................... FDA has reviewed its records and, under § 314.161, has determined that the drug products listed were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products 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 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: September 24, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–21201 Filed 9–30–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–4247] Patient-Focused Drug Development: Methods To Identify What Is Important to Patients; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability AGENCY: Food and Drug Administration, HHS. jbell on DSK3GLQ082PROD with NOTICES ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, FDA staff, and other stakeholders entitled ‘‘PatientFocused Drug Development: Methods VerDate Sep<11>2014 18:10 Sep 30, 2019 Jkt 250001 Tablet; Oral ....................... Injectable; Injection ........... Tablet; Oral ....................... Tablet; Oral ....................... Cream; Topical .................. Delayed-Release Tablet; Oral. To Identify What Is Important to Patients.’’ This guidance (Guidance 2) is the second in a series of four methodological guidance documents that FDA committed to develop to describe how to collect and submit information from patients and caregivers to be used for medical product development and regulatory decision-making. DATES: Submit either electronic or written comments on the draft guidance by December 30, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are 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 https://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): Dockets PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Applicant DENTSPLY Pharmaceutical, Inc. Hoffmann La-Roche, Inc. Baxter Healthcare, Corp. GlaxoSmithKline. Pfizer, Inc. GlaxoSmithKline. Genus Lifesciences, Inc. Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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– 2019–D–4247 for ‘‘Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access E:\FR\FM\01OCN1.SGM 01OCN1

Agencies

[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52113-52114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4329]


Determination That KENALOG (Triamcinolone Acetonide) Ointment, 
0.025% and 0.1%, 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. 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 
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 are 
no longer being marketed.

--------------------------------------------------------------------------------------------------------------------------------------------------------
      Application No.                   Drug name              Active ingredient(s)       Strength(s)         Dosage form/route          Applicant
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 011600................  KENALOG.........................  Triamcinolone          0.025%; 0.1%.........  Ointment; Topical....  Mylan
                                                               Acetonide.                                                           Pharmaceuticals,
                                                                                                                                    Inc.
NDA 012827................  ROBINUL.........................  Glycopyrrolate.......  1 milligram (mg).....  Tablet; Oral.........  Casper Pharma LLC.
                            ROBINUL FORTE...................  Glycopyrrolate.......  2 mg.................  Tablet; Oral.........
NDA 018029................  RITALIN-SR......................  Methylphenidate        20 mg................  Extended-Release       Novartis
                                                               Hydrochloride.                                Tablet; Oral.          Pharmaceuticals,
                                                                                                                                    Corp.
NDA 018164................  ANAPROX.........................  Naproxen Sodium......  Equivalent to (EQ)     Tablet; Oral.........  ATNAHS Pharma U.S.,
                                                                                      250 mg Base.                                  Ltd.
NDA 018405................  AYGESTIN........................  Norethindrone Acetate  5 mg.................  Tablet; Oral.........  Teva Branded
                                                                                                                                    Pharmaceutical
                                                                                                                                    Products R&D, Inc.
NDA 018452................  SEPTRA..........................  Sulfamethoxazole;      16 mg/milliliter       Injectable; Injection  Monarch
                                                               Trimethoprim.          (mL); 80 mg/mL.                               Pharmaceuticals,
                                                                                                                                    Inc.
NDA 018703................  ZANTAC 150......................  Ranitidine             EQ 150 mg Base.......  Tablet; Oral.........  GlaxoSmithKline.
                            ZANTAC 300......................   Hydrochloride.        EQ 300 mg Base.......  Tablet; Oral.........
                                                              Ranitidine
                                                               Hydrochloride.
NDA 019111................  TUSSIONEX PENNKINETIC...........  Chlorpheniramine       EQ 8 mg Chlorphenir-   Extended-Release       UCB, Inc.
                                                               Polistirex;            amine Maleate/5 mL;    Suspension; Oral.
                                                               Hydrocodone            EQ 10 mg Hydrocodone
                                                               Polistirex.            Bitartrate/5 mL.
NDA 019507................  KERLONE.........................  Betaxolol              10 mg; 20 mg.........  Tablets; Oral........  Sanofi-Aventis U.S.
                                                               Hydrochloride.                                                       LLC.
NDA 019537................  CIPRO...........................  Ciprofloxacin          EQ 100 mg Base; EQ     Tablet; Oral.........  Bayer Healthcare
                                                               Hydrochloride.         750 mg Base.                                  Pharmaceuticals,
                                                                                                                                    Inc.
NDA 019937................  ADENOCARD.......................  Adenosine............  3 mg/mL..............  Injectable; Injection  Astellas Pharma U.S.,
                                                                                                                                    Inc.
NDA 020415................  REMERON.........................  Mirtazapine..........  45 mg................  Tablet; Oral.........  Organon USA, Inc.
NDA 020528................  MAVIK...........................  Trandolapril.........  1 mg; 2 mg; 4 mg.....  Tablet; Oral.........  AbbVie, Inc.
NDA 020864................  MAXALT..........................  Rizatriptan Benzoate.  EQ 5 mg Base.........  Tablet; Oral.........  Merck Sharp & Dohme
                                                                                                                                    Corp.
NDA 020865................  MAXALT-MLT......................  Rizatriptan Benzoate.  EQ 5 mg Base.........  Orally Disintegrating  Do.
                                                                                                             Tablet; Oral.
NDA 020945................  NORVIR..........................  Ritonavir............  100 mg...............  Capsule; Oral........  AbbVie, Inc.
NDA 021131................  ZYVOX...........................  Linezolid............  400 mg/200 mL (2 mg/   Injectable; Injection  Pharmacia & Upjohn
                                                                                      mL).                                          Co.

[[Page 52114]]

 
NDA 021381................  XYLOCAINE DENTAL WITH             Epinephrine;           0.01 mg/mL/2%; 0.02    Injectable; Injection  DENTSPLY
                             EPINEPHRINE.                      Lidocaine              mg/mL/2%.                                     Pharmaceutical, Inc.
                                                               Hydrochloride.
NDA 021511................  COPEGUS.........................  Ribavirin............  200 mg; 400 mg.......  Tablet; Oral.........  Hoffmann La-Roche,
                                                                                                                                    Inc.
NDA 022325................  NEXTERONE.......................  Amiodarone             50 mg/mL.............  Injectable; Injection  Baxter Healthcare,
                                                               Hydrochloride.                                                       Corp.
NDA 050605................  CEFTIN..........................  Cefuroxime Axetil....  EQ 125 mg Base; EQ     Tablet; Oral.........  GlaxoSmithKline.
                                                                                      250 mg Base; EQ 500
                                                                                      mg Base.
NDA 050730................  ZITHROMAX.......................  Azithromycin.........  EQ 600 mg Base.......  Tablet; Oral.........  Pfizer, Inc.
NDA 050746................  BACTROBAN.......................  Mupirocin Calcium....  EQ 2% Base...........  Cream; Topical.......  GlaxoSmithKline.
NDA 205103................  YOSPRALA........................  Aspirin; Omeprazole..  81 mg/40 mg; 325 mg/   Delayed-Release        Genus Lifesciences,
                                                                                      40 mg.                 Tablet; Oral.          Inc.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug products listed were not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the Agency will 
continue to list the drug products 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 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: September 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21201 Filed 9-30-19; 8:45 am]
BILLING CODE 4164-01-P

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