Granules India Unit Gets USFDA Nod To Market ADHD Generic Drug
Hyderabad-based pharmaceutical company Granules India said it has received approval from the US health regulator to market a generic drug for attention deficit hyperactivity disorder.
Granules Pharmaceuticals Inc., a wholly owned subsidiary of the company, has received provisional approval from the U.S. Food and Drug Administration (USFDA) for an Abbreviated New Drug Application (ANDA) for Amphetamine extended-release orodispersible tablets in various strengths.
The company’s product is the generic equivalent of Adzenys XR-ODT and will be manufactured at Granules’ US-based facility in Chantilly, Virginia. The drug is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of approximately US$172 million, according to IQVIA (IMS Health).
The Hyderabad-based pharmaceutical company noted that there is currently only one approved generic and one authorized generic in the market, positioning Granules favorably to expand access to this critical treatment once launched.
ADHD is one of the most commonly diagnosed neurodevelopmental disorders in the United States and affects hundreds of millions of people worldwide. This approval further strengthens Granules’ US generic product portfolio and underscores its continued investments in complex dosage forms, patient-friendly delivery technologies and value-oriented healthcare solutions,” said Krishna Prasad Chigurupati, Chairman and MD, Granules India.
