Breckenridge Announces Tentative Approval of its ANDA for Dabigatran Etexilate Capsules (generic for Pradaxa®)

BERLIN, Conn. , April 22, 2022 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted tentative approval of its Abbreviated New Drug Application for Dabigatran Etexilate Capsules (generic for Pradaxa^®). This product development was a collaboration between Towa Pharmaceutical Europe, S.L. coupled with an external contract manufacturing organization. Breckenridge has the three strengths consistent with the brand – 75mg, 110mg, and 150mg. According to industry sales data, Pradaxa generated annual sales of $455 million during the twelve months ending February 2022. 

About Breckenridge: 
Breckenridge Pharmaceutical, Inc., a subsidiary of Towa Pharmaceutical (Osaka, Japan), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and quality of life of the patients we and our customers serve. 
www.bpirx.com

For further information, please contact: 
Breckenridge Pharmaceutical, Inc. 
Robert Gasparino, Associate Vice President – Business Development
Tel: 860-828-8140
E-mail: rgasparino@bpirx.com

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SOURCE Breckenridge Pharmaceutical, Inc.