“Breckenridge Pharmaceutical Inc. has received final approval for its abbreviated new drug application (ANDA) for Pomalidomide Capsules from the US Food and Drug Administration (USFDA),” Natco Pharma said in a regulatory filing.
In addition, Natco and Breckenridge have settled the patent litigation with Celgene (now part of Bristol-Myers Squibb) in the US district court for this product, the company added.
The company, however, did not share details of the settlement.
Celgene sells Pomalidomide Capsules under Brand name Pomalyst in the USA market which is indicated for the treatment of patients suffering from multiple myeloma cancer.
Natco Pharma said as per industry sales data, Pomalyst had annual sales of USD 957 million during the twelve months ending September 2020.
Shares of Natco Pharma were trading 0.50 per cent higher at Rs 910.40 apiece on BSE.