Zydus Lifesciences receives U.S. FDA approval for Scopolamine Transdermal System

Zydus Lifesciences (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  anesthesia, 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)