Zydus’ Nesher Pharmaceuticals receives final approval from USFDA

Zydus’ Nesher Pharmaceuticals receives final approval from USFDA

Agency News

Mumbai, Jul 19 : Zydus' Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA has received the final approval from the USFDA to market many new capsules.

The new capsules include Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release. Zydus' Nesher Pharmaceuticals can release the capsules of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 50 mg in the market.

The drug is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADH) which is a brain disorder characterized by an ongoing pattern of inattention and, or hyperactivity-impulsivity that interferes with functioning or development. Cadila Healthcare said in a filing with BSE.

It will be manufactured at Nesher Pharmaceuticals' manufacturing facility located at St. Louis, MO, USA. The group now has 269 approvals and has so far filed over 360 ANDAs since the commencement of the filing process in FY 2003-04. (UNI)