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Adalvo Restarts DCP Procedure for Dapagliflozin Film-Coated Tablets

Business
15 July 2024

Adalvo announces the restart of the DCP procedure for Dapagliflozin Film-Coated Tablets, with an anticipated EU Marketing Authorisation approval date in October 2024. 

Developed based on the reference brand Forxiga film-coated tablets, which is indicated in children aged 10 years and above, for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise, and in adults for the treatment of symptomatic chronic heart failure and chronic kidney disease. 

The brand sold approximately $11.5bn globally in 2023, having a global 3Y CAGR of +30%, according to IQVIA.   

Adalvo has developed one of the broadest diabetes pipelines in the industry with an extensive range of therapeutic options. Our diverse portfolio includes small molecules and peptide-based treatments, encompassing both oral and parenteral formulations, from short to long-acting range. This comprehensive approach makes diabetes care more manageable for patients worldwide.

There are no half-measures at Adalvo – 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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