[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0.025% and 0.1%, and Other Drug Products Were Not Withdrawn From Sale 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.

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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withdrawn from sale for reasons of safety or effectiveness.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).
    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


