Mylan Gets FDA Approval for Generic Version of Anticonvulsant Topamax(R) Sprinkle Capsules
Mylan Inc. has 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. Currently, Mylan has 121 ANDAs pending FDA approval representing $85.7 billion in annual brand sales, according to IMS Health.
