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Alvogen obtains European approvals for generic Gefitinib

05 September 2018

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:

“We are pleased with the approval for generic Gefitinib, and we look forward to leading the commercialization of this important product in our European markets. Alvogen has a promising pipeline of in-house generic projects and pending regulatory applications across its technological platform of complex generics including oral oncology portfolio, hormones and soft gels.”

European sales of Gefitinib in 2017 were US$136 million based on IQVIA data.

*Iressa® is a trademark of AstraZeneca