[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Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or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withdrawn from sale for reasons of safety or effectiveness.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