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. The approved product is equivalent to the reference listed drug Transderm Scop Transdermal System® 1 mg/3 days.
This marks the fifth ANDA approval for Zydus in its transdermal portfolio, showcasing the group’s strengths in manufacturing complex drug device dosage forms.
The 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.
Zydus will produce the Scopolamine Transdermal System at its transdermal manufacturing site at SEZ, Matoda, Ahmedabad.
According to IQVIA data (MAT June 2024), Scopolamine Transdermal System 1 mg/3 days had annual sales of USD $69.6 million in the United States.
With this approval, Zydus has now reached 400 approvals and has filed over 465 ANDAs since the commencement of its filing process in FY 2003-04. The ANDA filing figure is accurate as of June 30, 2024.
