Alvogen today announced that it has successfully concluded multiple registration applications for Gefitinib tablets. Alvogen received regulatory clearance for its product in several European countries and is among the first companies in Europe to obtain approval. Scientific approval has been obtained for Gefitinib 250 mg tablets.
Alvogen's product is a fully generic and bioequivalent version of Iressa®* tablets and has been fully developed in-house. The drug is indicated for non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK. Gefitinib 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. Marketing authorizations have been filed by Alvogen and its partners in 24 European countries.
Faysal Kalmoua, Executive Vice President of Alvogen’s Global Portfolio, commented:
European sales of Gefitinib in 2017 were US$136 million based on IQVIA data.
*Iressa® is a trademark of AstraZeneca