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Faulding receives FDA approval for generic anticonvulsant drug.


ELIZABETH, N.J.--(BUSINESS WIRE)--Nov. 1, 1996--

Seeks share of $264 million market

Faulding Inc.'s wholly owned subsidiary Wholly Owned Subsidiary

A subsidiary whose parent company owns 100% of its common stock.

Notes:
In other words, the parent company owns the company outright and there are no minority owners.
, Purepac Pharmaceutical Co., has received approval from the Food and Drug Administration to market clonazepam clonazepam /clo·naz·e·pam/ (klo-naz´e-pam) a benzodiazepine used as an anticonvulsant and as an antipanic agent.

clo·naz·e·pam
n.
 tablets, it was announced today by Richard F. Moldin, president and chief executive officer of Faulding Inc.

Clonazepam is an anticonvulsant anticonvulsant /an·ti·con·vul·sant/ (-kon-vul´sant) inhibiting convulsions, or an agent that does this.

an·ti·con·vul·sant
n.
A drug that prevents or relieves convulsions.
 used alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant) akinetic akinetic /aki·net·ic/ (a-ki-net´ik) pertaining to, characterized by, or causing akinesia.

akinetic

affected with akinesia.
 and myoclonic myoclonic

pertaining to myoclonus.


myoclonic epilepsy
see glycoproteinosis.

myoclonic jerk
a generalized seizure consisting of a jerk of most muscles in the body.
 seizures.

"This new drug is one of 15 new Faulding Inc. drugs on file for FDA approval and is the fourth FDA approval received by Faulding Inc. so far this calendar year. Purepac Pharmaceutical Co. received approval to market diclofenac delayed-release tablets, diflunisal tablets and indapamide tablets earlier this year. In addition, Purepac has commenced contract manufacturing of KADIAN(TM), a modified release morphine product, which is being marketed by Zeneca Inc.," said Moldin.

Purepac's 0.5 mg, 1mg, and 2mg clonazepam tablets are the generic equivalent of Klonopin(R). Total brand and generic revenues in 1995 were approximately $260 million. Product is expected to be available for shipment to customers first quarter, 1997.

Faulding Inc. develops, manufactures and markets human pharmaceuticals and medical devices. Faulding Inc. is the former Purepac Inc., which changed its name following its recent expansion beyond oral dosage forms into injectable drugs and drug delivery devices. The shares of Faulding Inc. are traded on NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
 under the symbol "FAUL." -0-

Note: Klonopin(R) is a registered trademark of Roche Laboratories.

CONTACT: Faulding Inc., Elizabeth

Lee Craker, 908/527-9100
COPYRIGHT 1996 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Nov 1, 1996
Words:258
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