The US Food & Drug Administration has granted marketing approval for ezetimibe
tablet (10 mg) to two Indian companies - Sun Pharma
and Zydus Cadila.
Ezetimibe, a generic version of Merck’s Zetia
tablet, is used to reduce high cholesterol levels.
“One of its wholly owned subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Zetia
tablet 10 mg),” stated Sun Pharmaceutical in a press release.
In a separate statement, Zydus Cadila
said, “Zydus has received the final approval from US FDA to market ezetimibe
tablet (10 mg). It will be produced at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.”
As per IMS, ezetimibe
tablet had annual sales of approximately $2.7 billion in the US for the 12 months ended April 2017.