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Alvogen submits European application for generic Pazopanib

26 March 2020

Alvogen today announced that it has submitted generic dossier applications for Pazopanib tablets.

Filing is targeted at several European countries and Alvogen believes it is the first company going for an approval in the EU. The pipeline covers both 200 and 400mg strengths.

Alvogen is targeting a generic and bioequivalent version of Votrient® tablets that has been fully developed in-house. Votrient® is a leading oncology drug originally developed by Novartis that is indicated for the treatment of renal cell cancer and soft tissue carcinoma with a global sales of close to $750 million as of 2019 (where $330 mio of sales is achieved in the US the rest in ROW regions).

The product was developed by Lotus Pharmaceuticals, an Alvogen affiliate, and is part of a comprehensive portfolio of solid oral dosage oncology drugs being developed by Alvogen.