Granules India on Thursday said it has received approval from the US health regulator for its generic Amphetamine mixed salts indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy.
Granules India introduced at present that it has acquired approval from the US Food & Drug Administration (US FDA) on Abbreviated New Drug Application (ANDA) filed for Amphetamine Mixed Immediate Release Tablets. The regulatory physique has granted approval to the Amphetamine Mixed Salts IR tablets within the capability 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 IR tablets are prescribed for the therapy of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
Commenting on the approval, Priyanka Chigurupati, Executive Director, GPI mentioned “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 gross sales of roughly $335 million within the US market within the final 12 months until October 2021. The permitted tablets might be manufactured at Granules manufacturing facility in Chantilly, Virginia.
Granules now has a complete of 47 ANDA approvals from US FDA together with 45 Final approvals and two tentative approvals.
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