FDAnews Drug Daily Bulletin

Mylan Pharmaceuticals has received tentative FDA approval for its abbreviated new drug application for generic Topamax 15- and 25-mg capsules, the company announced Sept. 10.

Ortho-McNeil’s Topamax (topiramate) capsules had U.S. sales of approximately $46 million during the 12-month period that ended in June, Mylan said. The company previously received tentative approval for 25-, 50-, 100- and 200-mg generic Topamax tablets. The drug is indicated for treating epilepsy and migraines.

Earlier this year, Mylan lost its bid to launch generic Topamax after the U.S. District Court for the District of New Jersey upheld the validity and enforceability of Ortho-McNeil’s ‘006 patent for Topamax.

The court issued a permanent injunction preventing Mylan from launching its generic epilepsy drug before the patent expires in September 2008. Mylan has appealed the ruling to the U.S. Court of Appeals for the Federal Circuit, according to court records.