Zydus Lifesciences Secures USFDA Nod for Scopolamine Transdermal System

Zydus Lifesciences Ltd obtained final approval from the USFDA to market its Scopolamine transdermal system, designed to prevent nausea and vomiting under various conditions. The product will be manufactured at Zydus's transdermal site in Ahmedabad and marks the company's fifth ANDA approval, with significant annual sales in the US.

Zydus Lifesciences Ltd has achieved a significant milestone, receiving final approval from the US Health regulator to market its Scopolamine transdermal system aimed at preventing nausea and vomiting in various scenarios.

The US Food and Drug Administration (USFDA) approved Zydus's Scopolamine transdermal system with a dosage of 1 mg/3 days, as stated in the company's regulatory filing.

This product will be manufactured at the group's transdermal manufacturing facility located in SEZ, Matoda, Ahmedabad.

Indicated for preventing nausea and vomiting after anesthesia, narcotic pain medicines, and surgery, the Scopolamine transdermal system is also effective against motion sickness-induced nausea and vomiting.

Zydus highlighted that this marks the fifth abbreviated new drug application (ANDA) approval in their transdermal portfolio, showcasing their expertise in complex drug device dosage forms.

According to IQVIA MAT data from June 2024, Scopolamine Transdermal System 1 mg/3 days generated annual sales of USD 69.6 million in the US.

(With inputs from agencies.)