Zydus subsidiary gets USFDA nod to market sleep disorder drug

Panacea Biotech

Zydus Pharmaceuticals’ subsidiary Nesher Pharmaceuticals has recently received the final approval from US Food and Drug Administration (USFDA) to market Dextroamphetamine Sulfate Extended-Release capsules (5 mg), which is used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy — a special type of sleep disorder.

Nesher Pharmaceuticals, a generic pharmaceutical manufacturer, will produce the drug at its facility in St. Louis, Missouri, US, Zydus Pharmaceuticals said in a BSE filing on Thursday.

With the fresh approval by the US drug regulator, Zydus Pharmaceuticals now has more than 120 approvals under its belt. The pharma major has also filed over 300 ANDAs since the comencement of the filing process in Financial Year 2003-04.

Nesher Pharmaceuticals had recently received approval from the USFDA to market in the US market Nystatin topical powder, which is used for treating skin infections.

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