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Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax Sprinkle Capsules

Thu, 10/15/2009 - 4:38am
Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has receivedapproval from the U.S. Food and Drug Administration (FDA) for its AbbreviatedNew Drug Application (ANDA) for Topiramate Capsules (Sprinkle), 15 mg and 25mg. Topiramate Capsules (Sprinkle) are the generic version of Ortho McNeil'santiconvulsant Topamax Sprinkle Capsules, 15 mg and 25 mg. For the 12 monthsending June 30, 2009, Topiramate Capsules (Sprinkle) had U.S. sales ofapproximately $58 million for the same strengths, according to IMS Health.
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