Daily Rules, Proposed Rules, and Notices of the Federal Government
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Revlimid (lenalidomide capsules), approved by FDA on December 27, 2005, is a thalidomide analogue indicated for the treatment of: Multiple myeloma, in combination with dexamethasone, in patients who have received at least one prior therapy and also in patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. Revlimid is designated as the reference listed drug, and therefore any ANDAs for generic lenalidomide capsules must demonstrate BE to the Revlimid prior to approval. There are no approved ANDAs for this product.
In June 2010, FDA posted on its Web site a draft guidance for industry on the Agency's recommendations for BE studies to support ANDAs for lenalidomide capsules. In that draft guidance, FDA recommended studies in the 15 milligram (mg) and 25 mg strengths of lenalidomide capsules to demonstrate BE. FDA has now determined that a BE study in the 15 mg strength is unnecessary and is revising the guidance to remove that recommendation. FDA also is revising the guidance to recommend that a request for a waiver of in vivo testing be submitted for the 2.5 mg, 5 mg, 10 mg, and 15 mg strengths based on: (1) Acceptable fasting and fed bioequivalence studies on the 25 mg strength, (2) proportional similarity of the formulations across all strengths, and (3) acceptable in vitro dissolution testing of all strengths.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on the design of BE studies to support ANDAs for lenalidomide capsules. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
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