Granules Pharma receives USFDA tentative approval for amphetamine ER ODT ANDA
Approval covers multiple strengths for ADHD treatment, to be manufactured at US facility
Granules Pharmaceuticals, a wholly owned subsidiary of Granules India, has received Tentative Approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Amphetamine Extended-Release Orally Disintegrating Tablets. The ANDA covers strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg and 18.8 mg. The product is the generic equivalent of ADZENYS XR-ODT and will be manufactured at Granules’ US-based facility in Chantilly, Virginia.
The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder. According to IQVIA (IMS Health), the estimated market size for this product is approximately USD 172 million. At present, the market has one approved generic and one authorised generic.
Commenting on the development, Dr Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India, said, “The tentative approval of this ANDA reaffirms Granules’ strategic focus on expanding its portfolio of complex and differentiated generics while strengthening its presence in the central nervous system (CNS) therapeutic area. ADHD is one of the most commonly diagnosed neurodevelopmental disorders in the United States and impacts hundreds of millions of people worldwide. At Granules, we remain committed to improving patient access by delivering high-quality, affordable medications across global markets.”
The approval adds to Granules’ generics portfolio in the United States and supports its work in dosage forms and delivery technologies,