Hyderabad, Jan. 8 -- Granules Pharmaceuticals, Inc., a wholly owned subsidiary of Granules India Limited, on Thursday announced it has received Tentative Approval (TA) from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Amphetamine Extended-Release Tablets.
The approval covers strengths of 5 mg, 10 mg, 15 mg, and 20 mg, the generic equivalent of DYANAVEL XR(R), indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), the Hyderabad based pharma company said in a release here.
The FDA has determined that Granules' ANDA is eligible for 180-day exclusivity, highlighting the company's growing strength in developing and commercializing complex and differentiated gen...