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Adalvo Restarts Regulatory Procedures for Dalbavancin DCP with Anticipated European Approval in May 2024

Business
13 March 2024

Adalvo is delighted to announce the restart of the DCP procedure for Dalbavancin powder, with an estimated approval date in May 2024.

This antibiotic niche product has been developed based on the reference brand Xydalba (EU), from Abbvie, and is indicated in the treatment of acute bacterial skin and skin structure infections. The product sold $260Mn globally in 2023, with a Global 3Y CAGR of 12%, according to IQVIA.

The development of Dalbavancin showcases Adalvo's capability to host a diverse and comprehensive anti-infectives portfolio.

We believe Adalvo is leading the way to secure one of the first generic approvals for Xydalba (EU) in Europe.

At Adalvo, there are no half-measures – we are always on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward.

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