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Cadila arm gets USFDA nod to market CNS capsules

Press Trust of India | New Delhi Jun 29, 2017 03:13 PM IST

Cadila Healthcare has received approval from the United States Food and Drug Administration (USFDA) to market Dextroamphetamine Sulfate extended-release capsules used for treatment of attention deficit hyperactivity disorder.

"Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA has received final approval from the USFDA to market Dextroamphetamine Sulfate extended-release capsules, 5 mg", Cadila Healthcare said in a statement today.

The drug will be produced at the Nesher Pharmaceuticals' manufacturing facility located at St Louis, MO, USA, it added.

Zydus Pharmaceuticals (USA) Inc is the US division of Cadila Healthcare.

"Dextroamphetamine is a central nervous system stimulant used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and in the treatment of narcolepsy", Cadila Healthcare said.

The group now has more than 120 approvals and has so far filed over 300 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process, it added.
Shares of Cadila Healthcare were today trading 0.96 per cent lower at Rs 522 per scrip on BSE.
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