Zydus’ Nesher gets USFDA’s nod for Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets

02 Nov 2017 Evaluate

Zydus Cadila’s Nesher Pharmaceuticals has received final approval from the United States Food and Drug Administration (USFDA) to market Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets in strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg. The drug is used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy and will be produced at the Nesher Pharmaceuticals’ manufacturing facility located at St. Louis, MO, USA.

The sales of Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are estimated at $416.5 million. The group now has more than 165 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The group now has more than 150 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.


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