Granules Pharma Secures USFDA Tentative Nod for Generic ADHD Drug

Granules India announced that its wholly owned US-based arm, Granules Pharmaceuticals, Inc., has secured a tentative approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets. This product is bioequivalent to its reference listed drug, Adzenys XR-ODT, used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The tentative approval signifies that Granules’ formulation has met all required quality, safety, and efficacy standards but awaits final clearance pending patent or exclusivity expiration of the reference drug.

Key Highlights:

Product: Generic Amphetamine Extended-Release Orally Disintegrating Tablets.

Therapeutic segment: Central Nervous System (ADHD treatment).

Reference brand: Adzenys XR-ODT (Neos Therapeutics).

Manufacturing base: Granules Pharmaceuticals Inc., Chantilly, Virginia, USA.

Approval type: Tentative—marketing to commence post-patent expiry.

Strategic impact: Strengthens Granules’ US generics portfolio and diversification in complex dosage forms.

Sources: Company filing to BSE; USFDA database.