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UCB S.A.'s Kremers Urban Pharmaceuticals Inc Receives FDA Approval For Extended Release Methylphenidate Hydrochloride


Wednesday, 10 Jul 2013 08:50am EDT 

UCB S.A. announced that Kremers Urban Pharmaceuticals Inc. (KU), its U.S. subsidiary focused on specialty generics, received approval from the U.S. Food and Drug Administration (FDA) for 18mg and 27mg extended release methylphenidate hydrochloride product, for which Concerta is the reference listed drug product. KU has begun launch operations and supplying the USA market with the product. KU also received tentative approval for the 36mg and 54mg. KU will be eligible for final approval after exclusivity expiration in September 2013. KU's extended release methylphenidate hydrochloride product is bioequivalent to Concerta QD marketed by ALZA Corporation (a unit of Johnson & Johnson). Each tablet is designed to be effective for 12-hours. 

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