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