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Adalvo Successfully Completes Pivotal BE Study for Azacitidine Film Coated Tablets

Business
02 July 2024

Adalvo announces the successful completion of the Pivotal BE study for Azacitidine 300mg film-coated tablets in adult patients with acute myeloid leukaemia (AML).

Following the successful EU Pivotal BE study, Azacitidine is now dossier-ready and Adalvo is preparing for DCP submission.
 
Based on the reference brand Onureg, Azacitidine recorded approximately $675 million in global sales in 2023, according to IQVIA.

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