Granules announced its US subsidiary has received marketing approval from the US FDA for Dexmethylphenidate HCl extended-release capsules for the treatment of attention-deficit hyperactivity disorder. Granules’ capsule product is bioequivalent to the reference listed drug (RLD), Focalin XR.
Priyanka Chigurupati, Executive Director of Granules Pharma said, “This approval from 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. We will be launching the product in the US market soon.”
The drug will be manufactured at the Granules manufacturing facility in Chantilly, Virginia. Granules now have a total of 30 ANDA approvals from the US FDA (28 Final approvals and 2 tentative approvals).
According to IQVIA Health, Dexmethylphenidate HCl ER Capsules had US sales of approximately $556 million* for the most recent twelve months ending in July 2020.
Focalin XR is a trademark of Novartis AG.