FDA Advisory Committee votes to remove fenfluramine 
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 FDA Advisory Committee votes to remove fenfluramine

LEXINGTON, Mass.--(BUSINESS WIRE)--September 29, 1995--
Interneuron Pharmaceuticals, Inc. (NASDAQ:IPIC) today announced that a
joint committee of the Endocrinologic and Metabolic Advisory Committee
and the Drug Abuse Advisory Committee of the U.S. cooking.net">food and Drug
Administration (FDA) has voted to remove fenfluramine and its isomers,
including dexfenfluramine, from Schedule IV of the Controlled
Substances Act.

The joint committee vote followed a September 28 meeting of the
Endocrinologic and Metabolic Advisory Committee to consider the
approval of dexfenfluramine under development by Interneuron as a
prescription anti-obesity treatment for obesity, provided additional
studies are performed. As previously announced, a decision was not
reached at the September 28 meeting because of the lack of a quorum,
although the vote was 3 to 2 in favor of approval. It is expected that
the vote will be completed as promptly as practicable.

[Talk about putting the best spin on a bizarre FDA advisory
committee meeting, one which almost canned dexfenfluramine!
The report on that is in a separate article. --SD]

Fenfluramine is currently marketed by Wyeth-Ayerst, a division of
American Home Products Corp. (NYSE:AHP) and dexfenfluramine is expected
to be marketed by Wyeth-Ayerst, with Interneuron retaining certain
manufacturing and co-promotion rights.

If dexfenfluramine is approved, milestone and royalty payments to
Interneuron from sales of dexfenfluramine will vary depending upon
whether or not the drug is scheduled.

Glenn L. Cooper, M.D., president and chief executive officer of
Interneuron, noted that a petition for the de-scheduling of
fenfluramine and its isomers was submitted in 1991. "The decision made
by the joint committee was based upon their review of an extensive body
of scientific and clinical evidence which indicates that fenfluramine
and dexfenfluramine do not have abuse potential," he added.

Controls imposed upon all Schedule IV substances relate to
record-keeping procedures for dispensing pharmacists and procedural
mandates for prescribing physicians.

Interneuron Pharmaceuticals is engaged in the development and
commercialization of innovative products for neurological and
behavi{*filter*}disorders.  Through three subsidiaries, Intercardia, Inc.,
Progenitor, Inc., and Transcell Technologies, Inc., Interneuron is
developing products and technologies related to cardiovascular disease,
gene therapy, stem cell biology, carbohydrate-based drug discovery and
drug transport.

Steve Dyer

Thu, 19 Mar 1998 03:00:00 GMT
 [ 1 post ] 

 Relevant Pages 

1. FDA Advisory Committee votes to remove fenfluramine

2. FDA Announces Steps to Improve Advisory Committee Processes

3. FDA Advisory Committee

4. FDA MedWatch- FDA Public Health Advisory issued for Crestor

5. Financial Conflicts of Interest and the Food and Drug Administration's Advisory Committees

6. Lyme Disease Advisory Committee

7. IDSA Letter on Tickborne Advisory Committee Bills

8. Pharmacist & P&T Committee Voting

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