Alvogen is claiming the first approvals in “several European countries” for its generic version of Celgene’s Revlimid (lenalidomide) capsules, after its Lotus Pharmaceuticals affiliate “successfully concluded multiple registration procedures” for the oncology drug. Lotus’ lenalidomide has been approved in European markets in seven strengths: 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg and 25mg capsules.
Noting that Iceland acted as the reference member state (RMS) in the decentralised marketing-authorisation procedure, Lotus said its European application for lenalidomide had been approved around a year after the...
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