[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43388-43390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19611]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4758]


Determination That CORTONE (Cortisone Acetate) Tablets 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Drug Products Were Not Withdrawn From Sale for Reasons of Safety or 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withdrawn from sale for reasons of safety or effectiveness.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, 
<a href="/cdn-cgi/l/email-protection#de8daabfbda7f095bfb0bb9eb8babff0b6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="55062134362c7b1e343b30153331347b3d3d267b323a23">[email protected]</span></a>.

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

[[Page 43389]]

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.

----------------------------------------------------------------------------------------------------------------
                                               Active                           Dosage form/
    Application No.         Drug name       ingredient(s)      Strength(s)          route           Applicant
----------------------------------------------------------------------------------------------------------------
NDA 007750............  CORTONE.........  Cortisone         25 milligrams     Tablet; Oral....  Merck & Co.,
                                           Acetate.          (mg).                               Inc.
NDA 008662............  NYDRAZID........  Isoniazid.......  100 mg/           Injectable;       Sandoz Canada
                                                             milliliter (mL).  Injection.        Inc.
NDA 010571............  COMPAZINE.......  Prochlorperazine  Equivalent to     Tablet; Oral....  SmithKline
                                           Maleate.          (EQ) 5 mg Base;                     Beecham
                                                             EQ 10 mg Base;                      Corporation d/b/
                                                             EQ 25 mg Base.                      a
                                                                                                 GlaxoSmithKline
                                                                                                 .
NDA 010670............  ORINASE.........  Tolbutamide.....  250 mg; 500 mg..  Tablet; Oral....  Pharmacia and
                                                                                                 Upjohn Co.
NDA 011127............  COMPAZINE.......  Prochlorperazine  2.5 mg; 5 mg; 25  Suppository;      SmithKline
                                                             mg.               Rectal.           Beecham
                                                                                                 Corporation d/b/
                                                                                                 a
                                                                                                 GlaxoSmithKline
                                                                                                 .
NDA 011808............  MELLARIL........  Thioridazine      30 mg/mL; 100 mg/ Concentrate;      Novartis
                                           Hydrochloride     mL.               Oral.             Pharmaceuticals
                                           (HCl).                                                Corp.
NDA 012145............  PROLIXIN........  Fluphenazine HCl  2.5 mg/5 mL.....  Elixir; Oral....  Apothecon Inc.,
                                                                                                 Division of
                                                                                                 Bristol Myers
                                                                                                 Squibb.
NDA 014713............  ETRAFON 2-10;     Perphenazine;     2 mg/10 mg; 2 mg/ Tablet; Oral....  Schering Corp.
                         ETRAFON 2-25;     Amitriptyline     25 mg; 4 mg/10
                         ETRAFON-A;        HCl.              mg; 4 mg/25 mg.
                         ETRAFON-FORTE.
NDA 014715............  TRIAVIL 2-10;     Perphenazine;     2 mg/10 mg; 2 mg/ Tablet; Oral....  New River
                         TRIAVIL 2-25;     Amitriptyline     25 mg; 4 mg/10                      Pharmaceuticals
                         TRIAVIL 4-10;     HCl.              mg; 4 mg/25 mg;                     Inc.
                         TRIAVIL 4-25;                       4 mg/50 mg.
                         TRIAVIL 4-50.
NDA 015539............  SERAX...........  Oxazepam........  10 mg; 15 mg; 30  Capsule; Oral...  Alpharma U.S.
                                                             mg; 15 mg.       Tablet; Oral....   Pharmaceuticals
                                                                                                 Division.
NDA 015922............  HALDOL..........  Haloperidol       EQ 2 mg Base/mL.  Concentrate;      Ortho-McNeil
                                           Lactate.                            Oral.             Pharmaceutical.
NDA 016584............  NAVANE..........  Thiothixene.....  1 mg; 2 mg; 5     Capsule; Oral...  Pfizer Inc.
                                                             mg; 10 mg; 20
                                                             mg.
NDA 016721............  DALMANE.........  Flurazepam HCl..  15 mg; 30 mg....  Capsule; Oral...  Valeant
                                                                                                 Pharmaceuticals
                                                                                                 International.
NDA 017923............  MELLARIL-S......  Thioridazine....  EQ 25 mg HCl/5    Suspension; Oral  Novartis
                                                             mL; EQ 100 mg                       Pharmaceuticals
                                                             HCl/5mL.                            Corp.
NDA 018374............  BACTRIM.........  Sulfamethoxazole  80 mg/mL; 16 mg/  Injectable;       Sun
                                           ; Trimethoprim.   mL.               Injection.        Pharmaceutical
                                                                                                 Industries,
                                                                                                 Inc.
NDA 018485............  ISOPTIN.........  Verapamil HCl...  2.5 mg/mL.......  Injectable;       Mt. Adams
                                                                               Injection.        Technologies
                                                                                                 LLC.
NDA 018596............  INTAL...........  Cromolyn Sodium.  10 mg/mL........  Solution;         King
                                                                               Inhalation.       Pharmaceuticals
                                                                                                 LLC.
NDA 018644............  WELLBUTRIN......  Bupropion HCl...  50 mg; 75 mg;     Tablet; Oral....  GlaxoSmithKline
                                                             100 mg.                             LLC.
NDA 019287............  DIZAC...........  Diazepam........  5 mg/mL.........  Injectable;       Pharmacia and
                                                                               Injection.        Upjohn Co.
NDA 019982............  ZEBETA..........  Bisoprolol        5 mg; 10 mg.....  Tablet; Oral....  Teva Branded
                                           Fumarate.                                             Pharmaceutical
                                                                                                 Products R&D,
                                                                                                 Inc.
NDA 020007............  ZOFRAN; ZOFRAN    Ondansetron HCl.  EQ 2 mg Base/mL.  Injectable;       Novartis
                         PRESERVATIVE                                          Injection.        Pharmaceuticals
                         FREE.                                                                   Corp.
NDA 020205............  PSORCON.........  Diflorasone       0.05%...........  Cream; Topical..  Taro
                                           Diacetate.                                            Pharmaceuticals
                                                                                                 North America
                                                                                                 Inc.
NDA 020947............  PENNSAID........  Diclofenac        1.5%............  Solution;         Nuvo
                                           Sodium.                             Topical.          Pharmaceuticals
                                                                                                 Inc.
NDA 021575............  FOSAMAX.........  Alendronate       EQ 70 mg Base/75  Solution; Oral..  Merck Sharp &
                                           Sodium.           mL.                                 Dohme Corp., a
                                                                                                 subsidiary of
                                                                                                 Merck & Co.,
                                                                                                 Inc.
NDA 050542............  AMOXIL..........  Amoxicillin.....  125 mg; 250 mg..  Chewable Tablet;  Dr. Reddy's
                                                                               Oral.             Laboratories,
                                                                                                 Inc.
NDA 050564............  AUGMENTIN `250';  Amoxicillin;      250 mg/EQ 125 mg  Tablet; Oral....  Do.
                         AUGMENTIN `500`.  Clavulanate       Base; 500 mg/EQ
                                           Potassium.        125 mg Base.
NDA 050581............  MEFOXIN IN        Cefoxitin Sodium  EQ 20 mg Base/    Injectable;       Merck & Co.,
                         SODIUM CHLORIDE                     mL; EQ 40 mg      Injection.        Inc.
                         0.9% IN PLASTIC                     Base/mL; EQ 20
                         CONTAINER;                          mg Base/mL; EQ
                         MEFOXIN IN                          40 mg Base/mL.
                         DEXTROSE 5% IN
                         PLASTIC
                         CONTAINER.
NDA 050591............  BACTROBAN.......  Mupirocin.......  2%..............  Ointment;         SmithKline
                                                                               Topical.          Beecham (Cork)
                                                                                                 Ltd., Ireland.
NDA 050594............  ERYCETTE........  Erythromycin....  2%..............  Swab; Topical...  Johnson &
                                                                                                 Johnson
                                                                                                 Consumer Inc.
NDA 050754............  AMOXIL..........  Amoxicillin.....  500 mg; 875 mg..  Tablet; Oral....  Dr. Reddy's
                                                                                                 Laboratories,
                                                                                                 Inc.
NDA 050760............  AMOXIL..........  Amoxicillin.....  200 mg/5 mL; 400  For Suspension;   Do.
                                                             mg/5 mL.          Oral.
----------------------------------------------------------------------------------------------------------------


[[Page 43390]]

    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 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19611 Filed 9-14-17; 8:45 am]
 BILLING CODE 4164-01-P


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