Zydus Lifesciences bags USFDA nod for Scopolamine Transdermal System 1 mg/3 days

Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Scopolamine Transdermal System 1 mg/3 days. (USRLD: Transderm Scop Transdermal System 1 mg/3 days).

This is the fifth ANDA approval for Zydus in the transdermal portfolio.

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 $69.6 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 FY 2003-04.

Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Zydus has been actively discovering and developing New Chemical Entities (NCEs) novel biologicals, several biosimilars and vaccines as a part of its innovation pipeline. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.

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