Zydus receives final approval from USFDA for Scopolamine Transdermal System 1 mg/3 days

BILKULONLINE

Ahmedabad, Aug 30: Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) 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, 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 $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.

(*as of 30th June 2024)