U.S. FDA approves Granules' generic version of ADHD drug

The US Food and Drug Administration has approved drugmaker Granules’ generic version of Amphetamine Mixed Salts, 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg Immediate Release tablets.

The drug is indicated for treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. The approved product is bioequivalent to the reference listed drug product Adderall of Teva Women’s Health Inc, Granules India said in a release on U.S. FDA approving the Abbreviated New Drug Application filed by its subsidiary Granules Pharmaceuticals Inc (GPI).

The product would be manufactured at Granules manufacturing facility in Chantilly, Virginia and expected to be launched shortly. Amphetamine Mixed Salts 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg IR Tablets had U.S. sales of around $335 million for the most recent twelve months ending in October 2021, the company said citing IQVIA Health numbers.

“We are pleased to receive the approval of Amphetamine Mixed Salts IR tablets within 10 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,” GPI Executive Director Priyanka Chigurupati said.

Granules said it now has a total of 47 ANDA approvals — 45 final approvals and two tentative approvals — from U.S. FDA.

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