Impax Laboratories has received tentative U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application (ANDA) for a generic version of Coreg CR (carvedilol phosphate) extended-release capsules, 10, 20, 40 and 80 mg. The company's ANDA is eligible for final approval upon the expiration of marketing exclusivity on May 7, 2018.
Carvedilol phosphate extended-release capsules had U.S. brand sales of approximately $206 million, according to IMS Health for the 12 months ending October 2017.