Nesher Pharmaceuticals, a subsidiary drug firm of Zydus has received FDA approval to market Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets —used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy —
Strengths of the drugs are 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg.
Zydus said the drug will be produced at the Nesher Pharmaceuticals’ manufacturing facility located in St. Louis, MO, USA.
The sales of Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are estimated at the US $416.5 million.
With the FDA nod of ADHD tablet, 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.