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US FDA grants approval for ezetimibe tablet to Sun Pharma & Zydus Cadila

Ezetimibe tablet, which had annual US sales of $ 2.7 bn, is used to reduce high cholesterol levels

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BS B2B Bureau Mumbai

Last Updated : Jun 13 2017 | 1:06 PM IST

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 (ezetimibe 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.