Zydus Lifesciences Receives U.S. FDA Approval to Market Scopolamine Transdermal System | Company News

Scopolamine 1 mg/3 day transdermal system had annual sales of $69.6 million in the U.S., the company said citing IQVIA MAT data from June 2024. Representative image

Zydus Lifesciences Ltd said on Friday it has received final approval from the US health regulator to market its scopolamine transdermal system indicated to prevent nausea and vomiting in different circumstances.

The approval granted by the US Food and Drug Administration (USFDA) is to market the scopolamine transdermal system at a dose of 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 following anesthesia, narcotic analgesics, and surgical procedures. 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 manufacturing complex drug device dosage forms,” ​​the company said.

The scopolamine 1 mg/3-day transdermal system had annual U.S. sales of $69.6 million, the company said, citing IQVIA MAT data from June 2024.

(Only the headline and image of this report may have been reworked by Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

First published: August 30, 2024 | 5:00 pm IS

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