Document ID: FDA-2016-N-1284-0001
Agency: fda
Document Type: Notice
Title: Determination That APRESOLINE (Hydralazine Hydrochloride) Injectable
and Other Drug Products Were Not Withdrawn From Sale for Reasons of
Safety or Effectiveness
Posted Date: 2016-06-06T04:00Z

[Federal Register Volume 81, Number 108 (Monday, June 6, 2016)]
[Notices]
[Pages 36312-36313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13181]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1284]

Determination That APRESOLINE (Hydralazine Hydrochloride) 
Injectable and Other Drug Products Were Not Withdrawn From Sale for 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withdrawn from sale for reasons of safety or effectiveness.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.

[[Page 36313]]

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 following 
table are no longer being marketed.

----------------------------------------------------------------------------------------------------------------
                                                   Active                         Dosage form/
   Application No.           Drug name         ingredient(s)     Strength(s)         route          Applicant
----------------------------------------------------------------------------------------------------------------
NDA 008303...........  APRESOLINE...........  Hydralazine      20 milligrams    Injectable;      Novartis
                                               Hydrochloride;.  (mg)/            Injection        Pharmaceutical
                                                                milliliter 10    Tablet; Oral.    s Corp.
                                                                mg; 25 mg; 50
                                                                mg; 100 mg.
NDA 017853...........  PROVENTIL............  Albuterol        Equivalent to    Tablet; Oral...  Schering-Plough
                                               Sulfate.         (EQ) 2 mg                         Corp.
                                                                base; EQ 4 mg
                                                                base.
NDA 019439...........  K-Dur................  Potassium        10               Extended-        Merck Sharp &
                                               Chloride.        milliequivalen   Release          Dohme, Corp.
                                                                ts (meq); 20     Tablet; Oral.
                                                                meq.
ANDA 060572..........  MYCOLOG-II...........  Nystatin;        100,000 units/   Ointment;        Delcor Asset
                                               Triamcinolone    gram; 0.1%.      Topical.         Corp.
                                               Acetonide.
ANDA 084343..........  KENALOG..............  Triamcinolone    0.025%; 0.1%...  Lotion; Topical  Delcor Asset
                                               Acetonide.                                         Corp.
----------------------------------------------------------------------------------------------------------------

    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: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13181 Filed 6-3-16; 8:45 am]
 BILLING CODE 4164-01-P