Granules’ generic for ADHD secures U.S. FDA tentative nod

Granules India, through a subsidiary, has received U.S. Food and Drug Administration’s (FDA’s) tentative approval for its generic of attention deficit hyperactivity disorder drug Adzenys-XR-ODT.

The product, indicated for the treatment of ADHD, has an estimated market size of $172 million, the Hyderabad-based generic drugmaker said, citing IQVIA (IMS Health) numbers. It will be manufactured at Granules’ U.S.-based facility located in Chantilly, Virginia.

The market currently has only one approved generic and one authorised generic. Granules is thus positioned favourably to expand access to the critical therapy upon launch, the parent company said, announcing subsidiary Granules Pharmaceuticals Inc. receiving tentative approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Amphetamine Extended-Release orally disintegrating tablets in 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg strengths.

“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 U.S. and impacts hundreds of millions of people worldwide,” CMD Krishna Prasad Chigurupati said.

The approval further strengthens the U.S. generics portfolio of the company, he said in a release.