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As of Nov 13, 2026, ANDA 210245 (Pomalidomide), held by Msn, was first approved by FDA on Sep 2, 2026, with 0 approved supplements and 0 published complete response letters.
First approved: Sep 2, 2026
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients:
in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. 1.1 Multiple Myeloma Pomalidomide capsules, in combination with dexamethasone, is indicated for adult patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
