Impax Receives Tentative FDA approval for generic version of Vytorin® (ezetimibe and simvastatin) tablets
Impax Laboratories, Inc. announced that Impax has received tentative approval from the U.S. Food and Drug Administration (FDA) for its
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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.
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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 4 million for the 12 months ending in December 2015.