[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Notices]
[Pages 58490-58491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24619]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3389]


Determination That PONDIMIN (Fenfluramine Hydrochloride) Tablets, 
20 Milligrams and 60 Milligrams, and PONDEREX (Fenfluramine 
Hydrochloride) Capsules, 20 Milligrams Were Withdrawn From Sale for 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 PONDIMIN (fenfluramine hydrochloride (HCl)) tablets, 20 
milligrams (mg) and 60 mg, and PONDEREX (fenfluramine HCl) capsules, 20 
mg, were withdrawn from sale for reasons of safety or effectiveness. 
The Agency will not accept or approve abbreviated new drug applications 
(ANDAs) for fenfluramine HCl tablets, 20 mg or 60 mg, or fenfluramine 
HCl capsules, 20 mg.

FOR FURTHER INFORMATION CONTACT: Robin Fastenau, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 240-
402-4510.

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 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (FD&C 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.

[[Page 58491]]

    PONDIMIN (fenfluramine HCl) tablets, 20 mg, and PONDEREX 
(fenfluramine HCl) capsules, 20 mg, were the subject of NDA 16-618, 
held by Wyeth Pharmaceuticals, and were initially approved on June 14, 
1973. PONDIMIN (fenfluramine HCl) sustained release tablets, 60 mg, was 
the subject of NDA 16-618, held by Wyeth Pharmaceuticals, and was 
initially approved in 1982. PONDIMIN and PONDEREX were indicated for 
treatment of obesity.
    In 1997, FDA asked that PONDIMIN (fenfluramine HCl) tablets and 
PONDEREX (fenfluramine HCl) capsules be withdrawn from the market after 
receiving new evidence that the products were associated with valvular 
heart disease (September 15, 1997, FDA Announces Withdrawal 
Fenfluramine and Dexfenfluramine (Fen-Phen), available on the Internet 
at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm179871.htm; 
see FDA November 1997 Fen-Phen Safety Update Information, available on 
the Internet at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm072820.htm). 
Wyeth Pharmaceuticals subsequently discontinued marketing these 
products. On October 8, 1998, FDA issued a Notice of Proposed 
Rulemaking proposing to include certain drug products on a list of drug 
products that had been withdrawn or removed from the market because 
such drugs products or components of such drug products had been found 
to be unsafe or not effective, and which could not be compounded under 
section 503A of the FD&C Act (63 FR 54082). FDA identified in that 
notice ``all drug products containing fenfluramine hydrochloride.'' The 
notice also noted that fenfluramine HCl tablets, formerly marketed as 
PONDIMIN tablets, were associated with valvular heart disease, and the 
manufacturer voluntarily withdrew the drug from the market. This 
proposed rule was finalized in 64 FR 10944 (March 8, 1999), 21 CFR 
216.24.
    In the Federal Register of May 5, 2004 (69 FR 25124), FDA issued a 
notice that it was withdrawing approval of 92 new drug applications and 
49 abbreviated new drug applications, including PONDIMIN (fenfluramine 
HCl) tablets and PONDEREX (fenfluramine HCl) capsules, under section 
505(e) of the FD&C Act. Consistent with Sec.  314.161 and its prior 
rulemaking on compounded drug products under 21 CFR 216.24, FDA has 
determined that PONDIMIN (fenfluramine HCl) tablets and PONDEREX 
(fenfluramine HCl) capsules were withdrawn from sale for reasons of 
safety or effectiveness. This determination is consistent with FDA's 
prior request and Wyeth Pharmaceutical's withdrawal of PONDIMIN 
(fenfluramine HCl) tablets and PONDEREX (fenfluramine HCl) capsules 
from the market for reasons of safety or effectiveness. The Agency 
previously removed PONDIMIN (fenfluramine HCl) tablets and PONDEREX 
(fenfluramine HCl) capsules from the list of drug products published in 
the Orange Book. FDA will not accept or approve any ANDAs that refer to 
these drug products.

    Dated: September 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24619 Filed 9-28-15; 8:45 am]
 BILLING CODE 4164-01-P