Breckenridge gets FDA blessing for generic Pomalyst

Sandra Levy
Senior Editor
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The Food and Drug Administration has cleared Breckenridge’s pomalidomide capsules, a generic of Pomalyst.

When taken along with dexamethasone, the drug is used to treat adults with multiple myeloma who have previously received at least two medicines to treat multiple myeloma, including a proteasome inhibitor and lenalidomide, and whose disease has become worse during treatment or within 60 days of finishing the last treatment.

Breckenridge has partnered with Natco Pharma for the development and manufacture of this product. Celgene, Breckenridge and Natco have settled the U.S. district court litigation with respect to this product, according to Breckenridge.

Pomalyst had a market value of $957 million during the 12 months ended September 2020, according to Breckenridge.