You are here

Generic Version of Anticonvulsant Topamax Sprinkle Capsules Approved by FDA

PITTSBURGH, Oct. 15 /PRNewswire-FirstCall/ -- Mylan Inc. (NASDAQ:MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules (Sprinkle), 15 mg and 25 mg.

Topiramate Capsules (Sprinkle) are the generic version of Ortho McNeil's anticonvulsant Topamax® Sprinkle Capsules, 15 mg and 25 mg. For the 12 months ending June 30, 2009, Topiramate Capsules (Sprinkle) had U.S. sales of approximately $58 million for the same strengths, according to IMS Health. Mylan has launched this product.

Source: Mylan

Recent Headlines

WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs