Impax Laboratories, Inc. announced that Impax has received tentative approval from the U.S. Food and Drug Administration (FDA) for its
Abbreviated New Drug Application (ANDA) for the generic version of the ezetimibe and simvastatin containing tablets, in 10 mg / 10 mg, 10 mg / 20 mg, 10 mg / 40 mg and 10 mg / 80 mg strengths.
According to IMS Health (NSP), U.S. brand sales of ezetimibe and simvastatin tablets, 10 mg / 10 mg, 10 mg / 20 mg, 10 mg / 40 mg and 10 mg / 80 mg were approximately $714 million for the 12 months ending in December 2015.
