Alvogen announced that it has successfully concluded multiple registration procedures for Lenalidomide capsules. Alvogen received regulatory clearance for its product in several European countries and believes it is the first company to obtain approval.
Scientific approval has been obtained for Lenalidomide 2.5, 5, 7.5, 10, 15, 20 and 25 mg capsules. Alvogen’s product is a fully generic and bioequivalent version of Revlimid® capsules and has been fully developed in-house. Revlimid® is a leading oncology drug indicated for several hematological disorders including multiple myeloma.
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.
The European approval follows last year’s submission of Alvogen’s Lenalidomide ANDA in the US and in several Asian countries. European sales of Lenalidomide in 2017 were $1,810 million based on IMS Midas data.