Impax’s Coreg CR generic gets tentative FDA approval

The Food and Drug Administration has approved specialty pharmaceutical company Impax Labs’ generic of GlaxoSmithKline’s Coreg CR (carvedilol phosphate) extended-release capsules.

The Bridgewater, N.J. company, which is set to be acquired by Amneal in the coming year, said that its application would become eligible for final approval once marketing exclusivity expires in May 2018. The drug is indicated to treat mild-to-severe heart failure, left ventricular dysfunction following myocardial infarction and hypertension.

Impax’s generic will be available in 10-, 20-., 40- and 80-mg dosage strengths. The product had U.S. brand sales of roughly $206 million for the 12 months ended October 2017, according to data from IQVIA.