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."
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