Zydus Lifesciences Gets USFDA Nod for Scopolamine Transdermal System
Aug 30, 2024 16:13
Zydus Lifesciences receives USFDA approval to market Scopolamine transdermal system for nausea and vomiting prevention. This is the fifth ANDA approval for Zydus in the transdermal portfolio.
Photograph: Courtesy Zydus.
New Delhi, Aug 30 (PTI) Zydus Lifesciences Ltd on Friday said it has received the final approval from the US Health regulator to market its Scopolamine transdermal system indicated to prevent nausea and vomiting under different circumstances.
The approval granted by the US Food and Drug Administration (USFDA) is to market the Scopolamine transdermal system of dosage 1 mg/3 days, Zydus Lifesciences said in a regulatory filing.
The Scopolamine transdermal system will be produced at the group's transdermal manufacturing site at SEZ, Matoda, Ahmedabad, it added.
Scopolamine transdermal System is indicated to prevent nausea and vomiting after anaesthesia, narcotic pain medicines, and surgery. It is also used to prevent nausea and vomiting caused by motion sickness.
"This is the fifth abbreviated new drug application (ANDA) approval for Zydus in the transdermal portfolio, leveraging the group's strengths in the manufacturing of complex drug device dosage forms," the company said.
Scopolamine Transdermal System 1 mg/3 days had annual sales of USD 69.6 million in the US, the company said citing IQVIA MAT June 2024 data.
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