Glenmark Pharmaceuticals Limited (NSE:GLENMARK)has received final U.S. Food and Drug Administration approval to market generic Trileptal (Oxcarbazepine) tablets.
Trileptal is currently manufactured by Roxane Laboratories Inc (Google Finance), Glenmark Pharmaceuticals Ltd. and Sun Pharmaceutical Industries Limited (BOM:524715) in three strength (150 mg, 300 mg and 600 mg) and is used alone or in combination with other drugs in the treatment of partial epileptic seizures in adults and children over the age of 4.
Trileptal was the 74th best selling brand name medication in 2005 according to Drug Topics.
"FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs," said Gary J. Buehler, director of FDA's Office of Generic Drugs. "The agency ensures that generic drugs are safe and effective, offering alternatives to Americans in choosing their prescription drugs."
[Source: U.S Food and Drug Administration]
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