[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Page 9225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03455]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-0948]


Determination That STAVZOR (Valproic Acid) Delayed-Release 
Capsules, 125 Milligrams, 250 Milligrams, and 500 Milligrams, Was 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 the Agency) has 
determined that STAVZOR (valproic acid) delayed-release capsules, 125 
milligrams (mg), 250 mg, and 500 mg, was not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve abbreviated new drug applications (ANDAs) for valproic acid, 
delayed-release capsules, 125 mg, 250 mg, and 500 mg, if all other 
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Na'Im R. Moses, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6223, Silver Spring, MD 20993-0002, 240-
402-3990.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products 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 known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are 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).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 mg, 
and 500 mg, is the subject of NDA 22-152, held by Banner Pharmacaps 
Inc., and initially approved on July 29, 2008. STAVZOR is indicated for 
acute treatment of manic or mixed episodes associated with bipolar 
disorder (with or without psychotic features), monotherapy and 
adjunctive therapy of complex partial seizures and simple and complex 
absence seizures, adjunctive therapy in patients with multiple seizure 
types that include absence seizures, and prophylaxis of migraine 
headaches.
    In a letter dated June 25, 2013, Banner Pharmacaps Inc. notified 
FDA that STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 
mg, and 500 mg, was being discontinued, and FDA moved the drug product 
to the ``Discontinued Drug Product List'' section of the Orange Book.
    Pharmaceutics International, Inc., submitted a citizen petition 
dated August 7, 2013 (Docket No. FDA-2013-P-0948), under 21 CFR 10.30, 
requesting that the Agency determine whether STAVZOR (valproic acid) 
delayed-release capsules, 125 mg, 250 mg, and 500 mg, was withdrawn 
from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that STAVZOR (valproic acid) delayed-release 
capsules, 125 mg, 250 mg, and 500 mg, was not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that STAVZOR (valproic acid) delayed-release 
capsules, 125 mg, 250 mg, and 500 mg, was withdrawn for reasons of 
safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of STAVZOR (valproic acid) delayed-
release capsules, 125 mg, 250 mg, and 500 mg, from sale. We have also 
independently evaluated relevant literature and data for possible 
postmarketing adverse events. We have reviewed the available evidence 
and determined that product was not withdrawn from sale for reasons of 
safety or effectiveness.
    Accordingly, the Agency will continue to list STAVZOR (valproic 
acid) delayed-release capsules, 125 mg, 250 mg, and 500 mg, in the 
``Discontinued Drug Product List'' section of the Orange Book. The 
``Discontinued Drug Product List'' delineates, among other items, drug 
products that have been discontinued from marketing for reasons other 
than safety or effectiveness. ANDAs that refer to STAVZOR (valproic 
acid) delayed-release capsules, 125 mg, 250 mg, and 500 mg, may be 
approved by the Agency as long as they meet all other legal and 
regulatory requirements for the approval of ANDAs. If FDA determines 
that labeling for this drug product should be revised to meet current 
standards, the Agency will advise ANDA applicants to submit such 
labeling.

    Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03455 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P