• FDA Releases Draft Guidance for Lenalidomide Bioequivalence Testing

    • 05 November 2012
    The US Food and Drug Administration (FDA) has released a new draft guidance regarding bioequivalence (BE) recommendations for lenalidomide capsules. Lenalidomide capsules, marketed by Celgene Corporation under the trade name Revlimid , are an analogue of Thalidomide and used to treat multiple myeloma. The latter was notorious in the late 1950s and early '60s for causing horrific birth defects in countries where the drug was approved-which did not, as FDA is proud to n...