MUMBAI: Zydus Lifesciences Limited received the final nod from the United States Food and Drug Administration (USFDA) to market its Scopolamine Transdermal System, delivering 1 mg of the medication over three days, it said in a release on Friday.
This product is a generic version of the Transderm Scop Transdermal System. This is the fifth Abbreviated New Drug Application (ANDA) approval for Zydus in its transdermal portfolio. The Scopolamine Transdermal System is indicated to prevent nausea and vomiting after anesthesia, narcotic pain medications, and surgery.
It is also used to prevent nausea and vomiting caused by motion sickness. The transdermal system will be manufactured at Zydus’s facility located in the Special Economic Zone (SEZ) in Matoda, Ahmedabad.
The annual sales for the Scopolamine Transdermal System in the United States stood at nearly USD 69.6 million as of June 2024, according to IQVIA data. With this latest approval, Zydus Lifesciences has achieved a total of 400 approvals and has submitted over 465 ANDAs since the initiation of its filing process in the financial year 2003-04.