Zydus Lifesciences Ltd. has been granted the final approval from the United States Food and Drug Administration (USFDA) to market Scopolamine Transdermal System 1 mg/3 days.

This is the fifth 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 Scopolamine Transdermal System will be produced at the group’s transdermal manufacturing site at SEZ, Matoda, Ahmedabad. 

Scopolamine Transdermal System 1 mg/3 days had annual sales of USD USD 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 FY 2003-04.