Zydus Life Gets Regulator Nod To Sell Post-Anaesthesia Drug In US

Zydus Lifesciences Ltd. on Friday said it has received approval from the United States Food and Drug Administration to market Scopolamine Transdermal System 1 mg/3 days to prevent nausea and vomiting after anaesthesia.

This is the fifth Abbreviated New Drug Application, or ANDA, approval for Zydus in the transdermal portfolio, leveraging the group’s strengths in the manufacturing of complex drug device dosage forms. Scopolamine Transdermal System is indicated to prevent nausea and vomiting after anaesthesia, narcotic pain medicines, and surgery.

It is also used to prevent nausea and vomiting caused by motion sickness. The drug will be manufactured at the group’s transdermal manufacturing site in a special economic zone at Matoda, Ahmedabad. Scopolamine Transdermal System 1 mg/3 days has annual sales of $69.6 million in the United States.

The group now has 400 approvals and has so far filed over 465 ANDAs since the commencement of the filing process in fiscal 2003-04.

Shares of Zydus Lifesciences were trading 2.04% higher at Rs 1,155.35 per share, as compared to a 0.34% advance in the BSE Sensex as of 1:25 p.m.