Evolus Completes FDA Premarket Approval Submission for Evolysse Dermal Fillers for 'Smile Lines'-March 2024-www.financetom.com

Evolus Completes FDA Premarket Approval Submission for Evolysse Dermal Fillers for 'Smile Lines'

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Evolus Completes FDA Premarket Approval Submission for Evolysse Dermal Fillers for 'Smile Lines'

Jun 24, 2024 6:51 AM

09:03 AM EDT, 06/24/2024 (MT Newswires) -- Evolus ( EOLS ) said Monday it submitted the final part of its premarket approval application to the US Food and Drug Administration for its Evolysse dermal filler products for nasolabial folds, also known as smile lines.

The application covers Evolysse Lift and its softer alternative Evolysse Smooth, Evolus ( EOLS ) said, noting that both dermal fillers met their pivotal trial's primary endpoints.

Evolus ( EOLS ) said it expects a decision from the FDA by the second half of 2025.

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