New Delhi: Zydus Lifesciences Ltd announced on Friday that it has received final approval from the U.S. Food and Drug Administration (USFDA) to market its Scopolamine transdermal system, designed to prevent nausea and vomiting under various conditions.
The USFDA approval allows Zydus to market the Scopolamine transdermal system in a 1 mg/3 days dosage. The company stated in a regulatory filing that the product will be manufactured at its transdermal manufacturing facility at SEL, Matoda, Ahmedabad, Gujarat.
The Scopolamine transdermal system is indicated for the prevention of nausea and vomiting associated with anesthesia, narcotic pain medications, and surgery. It is also used to prevent nausea and vomiting caused by motion sickness.
"This marks the fifth abbreviated new drug application (ANDA) approval for Zydus in its transdermal portfolio, showcasing the group's expertise in producing complex drug-device combinations," the company noted. According to data from IQVIA MAT for June 2024, the Scopolamine Transdermal System 1 mg/3 days had annual sales of USD 69.6 million in the U.S.
(Input from various sources)
(Rehash/Ankur Deka/MSM)