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FDA OKs first generic version of Topamax

April 2, 2009 at 10:20 AM   |   Comments

WASHINGTON, April 2 (UPI) -- The U.S. Food and Drug Administration has approved the first generic versions of Topamax tablets (topiramate) to prevent seizures.

The federal agency said prescribing information or labeling for generic topiramate will differ from the innovator drug, Topamax, because some uses of Topamax are protected by patents and exclusivity.

The labeling for both Topamax and generic topiramate contain a safety warning about metabolic acidosis, a condition associated with excessive acid in the blood that can cause symptoms such as tiredness, loss of appetite, irregular heartbeat and impaired consciousness.

The FDA said it approved topiramate tablets in several strengths to be marketed by: Roxane Laboratories Inc., Par Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Barr Laboratories Inc., TEVA Pharmaceuticals USA, Ranbaxy Laboratories Ltd., CIPLA Ltd., Glenmark Generics Ltd., Cobalt Laboratories, Apotex Inc., Zydus Pharmaceuticals USA, Aurobindo Pharma Ltd., Torrent Pharmaceuticals Ltd., Invagen Pharmaceuticals Inc., Unichem Laboratories Ltd., Sun Pharmaceuticals Ltd. and Pliva Hrvatska.

Information regarding topiramate is available at:

www.fda.gov/cder/foi/label/2006/020505s029,020844s024pi.pdf.

© 2009 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.
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