Granules Pharmaceuticals receives ANDA approval for Amphetamine mixed salts from US FDA
The product is bioequivalent to the Reference Listed Drug (RLD) product Adderall of Teva Women’s Health Inc, and would be manufactured at Granules manufacturing facility in Chantilly, Virginia
The US Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA), filed by Granules Pharmaceuticals, Inc (GPI) for Amphetamine mixed salts, 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg tablets. It is bioequivalent to the Reference Listed Drug (RLD) product Adderall of Teva Women’s Health Inc. The product would be manufactured at Granules manufacturing facility in Chantilly, Virginia and is expected to be launched shortly, Granules India notified via a statement.
It said that Amphetamine mixed salts IR tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
Further, according to the statement, Granules now has a total of 47 ANDA approvals from the US FDA (45 final approvals and two tentative approvals).
It also mentioned that Amphetamine mixed salts 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg tablets had the US sales of approximately $335 million for the most recent twelve months ending in October 2021, according to IQVIA Health.
Adderall is a registered trademark of Teva Women’s Health Inc, the statement concluded.
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