Zydus Lifesciences Secures FDA Approval for Scopolamine Transdermal System
Zydus Lifesciences gets FDA nod for Scopolamine Transdermal System, set for production and market launch.
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.
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