FDA APPROVES MYLAN'S GENERIC TOPIRAMATE
Mylan Pharmaceuticals has received final approval from the FDA for its abbreviated new drug application for topiramate tablets, 25, 100 and 200 mg.
The drug is the generic version of Ortho-McNeil's Topamax Tablets, which is indicated for the treatment of epileptic seizures. Topamax had U.S. sales of approximately $1.37 billion for the above three strengths for the 12-month period ending June 30, according to IMS Health. Mylan also received tentative approval for the 50-mg dosage of topiramate.
Mylan was the first company to file for generic versions of these strengths of the drug and is therefore eligible for 180 days of market exclusivity. The FDA has indicated that the exclusivity will begin on the first commercial launch of the Mylan product or will be decided by a court decision on which no appeal can be taken, according to the company.
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