Breckenridge Announces Final Approval of its ANDA for Everolimus Tablets (generic for Zortress®)
BERLIN, Conn., June 1, 2021 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Everolimus Tablets (generic for Zortress®). This product was developed in collaboration with Natco Pharma Limited. According to industry sales data, Zortress and its therapeutic equivalents generated annual sales of $162 million during the twelve months ending March 2021. Breckenridge plans to launch Everolimus Tablets in 0.25mg, 0.5mg and 0.75mg strengths during the third quarter of 2021 in a blister card packaging configuration.
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SOURCE Breckenridge Pharmaceutical, Inc.