Amphetamine Mixed Salts IR tablets are prescribed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy

Hyderabad: Granules India announced today that it has received approval from the US Food & Drug Administration (US FDA) on Abbreviated New Drug Application (ANDA) filed for Amphetamine Mixed Immediate Release Tablets. The regulatory body has granted approval to the Amphetamine Mixed Salts IR tablets in the capacity of 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg. It is a bioequivalent to the reference listed drug product (RLD) Adderall, a registered trademark of Teva Women’s Health Inc. Amphetamine Mixed Salts

 US pharmaceutical market US FDA health news generic medicine ANDA tablets are prescribed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Commenting on the approval, Priyanka Chigurupati, Executive Director, GPI said “We are pleased to receive the approval of Amphetamine Mixed Salts IR tablets within ten months of ANDA filing, which is a controlled substance (C-II) product. It will surely be a valuable addition to our growing product portfolio in the US market” According to IQVIA Health, Amphetamine Mixed Salts Immediate Release Tablets had made sales of approximately $335 million in the US market in the last 12 months till October 2021. The approved tablets will be manufactured at Granules manufacturing facility in Chantilly, Virginia. Granules now has a total of 47 ANDA approvals from US FDA including 45 Final approvals and two tentative approvals.