Zydus Lifesciences Secures FDA Approval for Scopolamine Transdermal System

Zydus Lifesciences Ltd announced on Friday that it has received final approval from the U.S. Food and Drug Administration (FDA) to market its Scopolamine Transdermal System, a product designed to prevent nausea and vomiting under various conditions.

The FDA approval covers the 1 mg/3 days dosage form of the Scopolamine Transdermal System. Production will take place at Zydus's transdermal manufacturing facility located in SEZ, Matoda, Ahmedabad.

The Scopolamine Transdermal System is indicated for preventing nausea and vomiting following anesthesia, narcotic pain medications, and surgery. It is also effective against motion sickness.

This approval marks the fifth Abbreviated New Drug Application (ANDA) approval for Zydus in its transdermal product lineup, highlighting the company’s expertise in manufacturing complex drug-device combinations. According to IQVIA data for the period ending June 2024, the Scopolamine Transdermal System 1 mg/3 days generated annual sales of $69.6 million in the U.S.

The successful approval and upcoming market introduction of this product are expected to enhance Zydus’s presence in the pharmaceutical industry and capitalize on the growing demand for effective transdermal therapies.