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FDA Approves Generic Topamax to Prevent Seizures

March 30, 2009 - The U.S. Food and Drug Administration has approved the first generic versions of Topamax tablets (topiramate) to prevent seizures.

"Generic drugs undergo a rigorous scientific review to ensure they will provide patients with the same dose of high quality, safe and effective active ingredient as the name brand product," said Gary Buehler, director of the Office of Generic Drugs in the Center for Drug Evaluation and Research. "The FDA is committed to providing access to safe and effective generic drugs as soon as the law permits when a brand name drug’s patents and exclusivities expire."

Topiramate tablets in several different strengths have been approved to be marketed by the following firms: 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.

Prescribing information, or labeling, for generic topiramate will differ from the innovator drug, Topamax, because some uses of Topamax continue to be protected by patents and exclusivity.

The labeling for Topamax and generic topiramate contains an important safety warning about metabolic acidosis, a condition associated with excessive acid in the blood, which can cause symptoms such as tiredness, loss of appetite, irregular heartbeat, and impaired consciousness. Health care professionals should perform a blood test to monitor the level of a patient’s serum bicarbonate.

The use of topiramate has been associated with serious eye problems, such as a sudden decrease in vision and a blockage of fluid in the eye causing increased pressure in the eye. Patients taking topiramate should contact their health care professional immediately if they have a loss in vision or experience eye pain. These problems can lead to blindness if not treated right away.

For more information on topiramate, please see the FDA Patient Information Sheet: www.fda.gov/cder/foi/label/2006/020505s029,020844s024pi.pdf

For information on generic drugs, visit: www.fda.gov/cder/consumerinfo/generic_text.htm

Source: Food and Drug Administration

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