Granules India Subsidiary Gets US FDA Tentative Nod For ADHD Generic Drug

Granules Pharmaceuticals Inc has received tentative approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets, the company announced in a press release today.

The regulator approved the generic equivalent of ADZENYS XR-ODT® in strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg and 18.8 mg. Granules stated that it will manufacture the product at its US-based facility located in Chantilly, Virginia. The medication is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

According to IQVIA (IMS Health) data cited by the company, the product possesses an estimated market size of approximately $172 million. A company statement noted that the market currently holds only one approved generic and one authorised generic. Granules stated this landscape positions the firm favourably to expand access to this critical therapy upon launch.

The company stated that this approval further strengthens its US generics portfolio. The filing also highlighted continued investments in complex dosage forms, patient-friendly delivery technologies and value-driven healthcare solutions.