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Breckenridge Announces Final Approval of its ANDA for Everolimus Tablets (generic for Afinitor®)

Breckenridge Announces Final Approval of its ANDA for Everolimus Tablets (generic for Afinitor®) News provided by Share this article Share this article BERLIN, Conn., March 8, 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 Afinitor ®). This product was developed in collaboration with Natco Pharma Limited. According to industry sales data, Afinitor and its therapeutic equivalents generated annual sales of $712 million during the twelve months ending December 2020.  Breckenridge plans to launch Everolimus Tablets in 2.5mg, 5mg and 7.5mg strengths during the second quarter of 2021 in a blister card packaging configuration. Breckenridge s launch of the product s 10mg strength is based on terms that are presently confidential and will be announced at a later date. 

Natco s marketing partner gets USFDA nod for cancer drug - The Hindu BusinessLine

Natco s marketing partner gets USFDA nod for cancer drug - The Hindu BusinessLine
thehindubusinessline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thehindubusinessline.com Daily Mail and Mail on Sunday newspapers.

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