Adalvo submits dossier application for Enzalutamide Soft Gel Capsule 40mg

19 July 2021

Adalvo is pleased to announce that following the successful compilation of all necessary requirements, we have submitted our dossier for Enzalutamide, and did proceed for filing via several DCP procedures in Europe.

Our product is Enzalutamide Soft Gel Capsule 40mg that has been developed based on the reference brand Xtandi (Astellas). This Adalvo product has been developed at the Lotus site, Alvogen's Taiwanese state-of-the-art oncology dedicated facility.

We believe we are among the first companies to file in EU and expect Adalvo to be among the first companies getting an approval and launching the product.

Enzalutamide is a used in the treatment of metastatic hormone-sensitive prostate cancer. The brand has been selling $3.7 billion across the globe in 2020, according to IQVIA.

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Disclaimer: Enzalutamide which is subject to patent protection is currently not offered or made available in countries where patents are in force