Zydus Lifesciences gets USFDA’s final approval for Scopolamine Transdermal System

30 Aug 2024 Evaluate

Zydus Lifesciences 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 the company 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 $69.6 million 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 (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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