Zydus Lifesciences Limited received final approval from the United States Food and Drug Administration (USFDA) to market Scopolamine Transdermal System 1 mg/3 days. (USRLD: 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 systems will be produced at the group's transdermal manufacturing site at SEZ, Matoda, Ahmedabad. Scopolamine Transder Mal System 1 mg/3 days had annual sales of USD69.6 mn in the United States (IQVIA MAT June 2024).
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.