[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7583-7584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3232]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-P-0701]


Determination That WILPO (phentermine hydrochloride) Tablets, 8 
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or 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) has determined that 
WILPO (phentermine hydrochloride) Tablets, 8 Milligrams (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withdrawn from sale for reasons of safety or effectiveness.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 phentermine hydrochloride tablets, 8 mg, if 
all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nam Kim, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, rm. 6320, Silver Spring, MD 20993-0002, 301-796-3472.

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 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 only clinical data 
required in an ANDA are data to show that the drug that is the subject 
of the ANDA is bioequivalent to the listed drug.
    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.
    WILPO (phentermine hydrochloride) Tablets, 8 mg is the subject of 
NDA 012737, held by Sandoz, Inc. WILPO is indicated in the management 
of exogenous obesity as a short term adjunct (a few weeks) in a regimen 
of weight reduction based on caloric restriction.
    WILPO (phentermine hydrochloride) Tablets, 8 mg, is currently 
listed in the ``Discontinued Drug Product List'' section of the Orange 
Book.
    KVK-Tech, Inc. (KVK-Tech), submitted a citizen petition dated 
September 22, 2011 (Docket No. FDA-2011-P-0701), under 21 CFR 10.30, 
requesting that the Agency determine whether WILPO (phentermine 
hydrochloride) Tablets, 8 mg, was withdrawn from sale for reasons of 
safety or effectiveness. After considering the citizen petition and 
reviewing

[[Page 7584]]

Agency records and based on the information we have at this time, FDA 
has determined under Sec.  314.161 that WILPO (phentermine 
hydrochloride) Tablets, 8 mg, was not withdrawn for reasons of safety 
or effectiveness. The petitioner KVK-Tech has identified no data or 
other information suggesting that WILPO (phentermine hydrochloride) 
Tablets, 8 mg, was withdrawn for reasons of safety or effectiveness. We 
have carefully reviewed our files for records concerning the withdrawal 
of WILPO (phentermine hydrochloride) Tablets, 8 mg, from sale. We have 
also independently evaluated relevant literature and data for possible 
postmarketing adverse events. We have found no information that would 
indicate that this product was withdrawn from sale for reasons of 
safety or effectiveness.
    Accordingly, the Agency will continue to list WILPO (phentermine 
hydrochloride) Tablets, 8 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 WILPO (phentermine hydrochloride) 
Tablets, 8 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 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3232 Filed 2-10-12; 8:45 am]
BILLING CODE 4160-01-P