81 FR 52440 - Determination That BENTYL (Dicyclomine Hydrochloride) Syrup and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 152 (August 8, 2016)

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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.

[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52440-52441]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18707]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2062]


Determination That BENTYL (Dicyclomine Hydrochloride) Syrup 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Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety 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withdrawn from sale for reasons of safety or effectiveness.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, 
[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

[[Page 52441]]

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 007961.......................  BENTYL..............  Dicyclomine           10 milligrams (mg)/5       Syrup; Oral.........  Aptalis Pharma US, Inc.
                                                          Hydrochloride (HCl).  milliliters (mL).
NDA 011721.......................  NEPTAZANE...........  Methazolamide.......  25 mg; 50 mg.............  Tablet; Oral........  Lederle Laboratories.
NDA 016418.......................  INDERAL.............  Propranolol HCl.....  10 mg; 20 mg; 40 mg; 60    Tablet; Oral........  Wyeth Pharmaceuticals,
                                                                                mg.                                              Inc., a subsidiary of
                                                                                                                                 Pfizer Inc.
NDA 021410.......................  AVANDAMET...........  Metformin HCl;        500 mg/Equivalent to (EQ)  Tablet; Oral........  SmithKline Beecham
                                                          Rosiglitazone         2 mg base; 500 mg/EQ 4                           (Cork) Ltd, Ireland.
                                                          Maleate.              mg base; 1 g/EQ 2 mg
                                                                                base; 1 g/EQ 4 mg base.
NDA 021494.......................  AXID................  Nizatidine..........  15 mg/mL.................  Solution; Oral......  Braintree Laboratories,
                                                                                                                                 Inc.
NDA 050505.......................  GARAMYCIN...........  Gentamicin Sulfate..  EQ 2 mg base/mL..........  Injectable;           Schering-Plough Corp.
                                                                                                           Intrathecal.
ANDA 061716......................  GARAMYCIN...........  Gentamicin Sulfate..  EQ 1 mg base/mL; EQ 40 mg  Injectable;           Schering-Plough Corp.
                                                                                base/mL.                   Injection.
ANDA 061739......................  GARAMYCIN...........  Gentamicin Sulfate..  EQ 10 mg base/mL.........  Injectable;           Schering-Plough Corp.
                                                                                                           Injection.
ANDA 080745......................  ARISTOCORT and        Triamcinolone         0.5%.....................  Ointment; Topical...  Astellas Pharma US, Inc.
                                    ARISTOCORT A.         Acetonide.
ANDA 083944......................  KENALOG.............  Triamcinolone         0.5%.....................  Ointment; Topical...  Delcor Asset Corp.
                                                          Acetonide.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18707 Filed 8-5-16; 8:45 am]
 BILLING CODE 4164-01-P