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Zydus receives final approval from USFDA for Scopolamine Transdermal System 1 mg/3 days

Ahmedabad, India, 30 August, 2024

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to market Scopolamine Transdermal System 1 mg/3 days. (USRLD: Transderm Scop Transdermal System ® 1 mg/3 days). This is the fifth ANDA approval for Zydus in the transdermal portfolio, leveraging the group’s strengths in the manufacturing of complex drug device dosage forms.

zydus

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. The Scopolamine Transdermal System will be produced at the group’s transdermal manufacturing site at SEZ, Matoda, Ahmedabad.

Scopolamine Transdermal System 1 mg/3 days had annual sales of USD $69.6 mn in the United States (IQVIA MAT June 2024).

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