Granules Pharma Amphetamine Mixed Salts gets USFDA okay to treat ADHD, narcolepsy

Hyderabad: Granules India Limited has recently announced that the US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of Granules India Limited, for Amphetamine Mixed Salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg Immediate-Release Tablets.

It is bioequivalent to the reference listed drug product (RLD), _Adderall of Teva Women's Health Inc. The product would be available for the US market shortly.

The drug is indicated for the treatment of narcolepsy and Attention Deficit Hyperactivity Disorder (ADHD).

Commenting on the approval Ms. Priyanka Chigurupati, Executive Director, GPI, said "We are pleased to receive the approval of the controlled substance product and will surely be a valuable addition to our growing product portfolio in the US market. We will be launching the product shortly."

Granules now have a total of 47 ANDA approvals from the US FDA (45 Final approvals and 2 tentative approvals). The current annual U.S. market for Amphetamine Mixed Salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg Immediate Release Tablets strengths is approximately $ 335 Million, according to MAT, Oct 2021 IQVIA/IMS Health.

Granules India's US subsidiary had earlier received marketing approval from the USFDA for Dexmethylphenidate HCl extended-release capsules for the treatment of attention-deficit hyperactivity disorder.

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