[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81780-81782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27855]


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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Products Were Not Withdrawn From Sale for Reasons of Safety or 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.

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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withdrawn from sale for reasons of safety or effectiveness.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