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UCB'Kremers Gets FDA Approval For Extended Release Methylphenidate Hydrochloride

UCB announced Wednesday that its U.S. subsidiary, Kremers Urban Pharmaceuticals Inc. or KU, received approval from the U.S. Food and Drug Administration or 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 US-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 (JNJ). Each tablet is designed to be effective for 12-hours.

In September 2011, KU announced that it has reached a settlement dismissing all pending litigation arising from its Abbreviated New Drug Application or ANDA to market an extended release methylphenidate hydrochloride product. The settlement allows Kremers Urban to commercially launch its methylphenidate ANDA product under the existing ALZA Corporation patents.

UCB noted that the launch of KU's new generic product was already considered in its 2013 financial guidance.

by RTT Staff Writer

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