Granules India Subsidiary Receives USFDA Tentative Approval for Generic ADHD Drug with Exclusivity
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Granules India Subsidiary Receives USFDA Tentative Approval for Generic ADHD Drug with Exclusivity

Granules Pharmaceuticals, Inc., a subsidiary of Granules India, has received tentative approval from the USFDA for its generic Amphetamine Extended-Release Tablets, equivalent to DYANAVEL XR. The application is eligible for 180-day exclusivity, a significant step for the company's complex generics strategy. This marks the second recent tentative approval for the company's ADHD treatments, reinforcing its capabilities in the US market and its focus on the central nervous system therapeutic space.

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