Pharmaceutical firm Granules’ U.S. subsidiary has received marketing approval from U.S. Food and Drug Administration (USFDA) for Dexmethylphenidate HCl extended-release capsules.A bioequivalent of Focalin XR, which is a trademark of Novartis AG, the approved product is for use in treatment of attention-deficit hyperactivity disorder. The approval of Dexmethylphenidate XR, a complex, extended-release C-II product, is a good addition to the portfolio. The drug will be manufactured at the Granules manufacturing facility in Chantilly, Virginia, the company said.“We will be launching the product in the U.S. market soon,” said Priyanka Chigurupati, Executive Director of Granules Pharmaceuticals Inc.The company received the approval within 13 months of the filing “reiterates our strength in the development of complex generics,” she said. Granules now has 30 ANDA approvals from the USFDA (28 final approvals and 2 tentative approvals).Citing IQVIA Health numbers, a release from Granules said Dexmethylphenidate HCl ER Capsules had U.S. sales of approximately $556 million for the most recent twelve months ended in July 2020.
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