Breckenridge Announces Tentative Approval of its ANDA for Dabigatran Etexilate Capsules (generic for Pradaxa®)
Berlin, Connecticut, April 22, 2022
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.
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