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  • PDUFA date for ET 101 from Azurity Pharma to treat...

PDUFA date for ET 101 from Azurity Pharma to treat epilepsy is now extended to 6 November 2021.

Read time: 1 mins
Published:17th Aug 2021
Azurity Pharma is now responsible for all regulatory activities for ET 101 which it acquired from Eton Pharma.

During the quarter, Azurity submitted responses to the FDA’s review questions which the FDA deemed to be an amendment to the application and resulted in the FDA extending the application’s PDUFA date to November 6, 2021. Eton believes all FDA requests have been responded to and expects the application to be approved on or before the new PDUFA date.

Condition: Epilepsy
Type: drug

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