New Delhi : Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals, USA has received approval from the US health regulator to market Dextroamphetamine IR tablets, used in treating nervous system disorders, in the American market.
Nesher has received its first abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) to market Dextroamphetamine IR Tabs, Zydus Cadila said in a statement.
“The drug falls in the CNS stimulant segment and is the first product to be developed by the R&D team at Nesher. It will be produced at the manufacturing facility based at St. Louis, Missouri, USA,” it added.
As per IMS sales data, the estimated sales for Dextroamphetamine IR Tabs is $40.6 million.