Hyderabad-based pharma company Granules India has received marketing approval from the US health regulator FDA for its Dexmethylphenidate Hydrochloride extended-release capsules. The medicine is used for the treatment of attention-deficit hyperactivity disorder. Granules’ capsule product is bioequivalent to the reference listed drug (RLD), Focalin XR.
“This approval for Granules Pharmaceuticals, received within 13 months of filing reiterates our strength in the development of complex generics. The approval of Dexmethylphenidate XR, a complex, extended-release C-II product, is a good addition to our portfolio,’’ said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals in a release.
The company will be launching the product in the US market soon. The drug will be manufactured at the Granules manufacturing facility in Chantilly, Virginia. Granules has 30 ANDA or abbreviated new drug application approvals from the US FDA (28 final approvals and two tentative approvals). According to data firm IQVIA Health, Dexmethylphenidate HCl ER capsules had US sales of about $556 million for the most recent 12 months ending in July 2020. Focalin XR is a trademark of Novartis AG.
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