Granules Pharmaceuticals gets FDA tentative approval for ADHD treatment

Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited, announced on December 22, 2025, that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Amphetamine Extended-Release Orally Disintegrating Tablets. This generic equivalent of ADZENYS XR-ODT® will be manufactured at Granules' facility in Chantilly, Virginia, and will be available in multiple strengths ranging from 3.1 mg to 18.8 mg.

The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), a condition affecting millions globally. According to IQVIA (IMS Health), the estimated market size for this product is approximately $172 million. This tentative approval positions Granules favorably, as the market currently features only one approved generic and one authorized generic for this critical therapy.

Dr. Krishna Prasad Chigurupati, chairman and managing director, highlighted that this approval reinforces Granules' focus on expanding its portfolio of complex and differentiated generics, particularly within the central nervous system therapeutic area. The company remains committed to enhancing patient access to high-quality, affordable medications worldwide. This milestone further strengthens Granules' US generics portfolio and its investment in complex dosage forms and patient-friendly delivery technologies.