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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

BS B2B Bureau  |  Mumbai 

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

The US Food & Drug Administration has granted marketing approval for tablet (10 mg) to two Indian companies - and Ezetimibe, a generic version of Merck’s 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 (tablet 10 mg),” stated Sun Pharmaceutical in a press release.

In a separate statement, said, “Zydus has received the final approval from US FDA to market tablet (10 mg). It will be produced at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.”

As per IMS, tablet had annual sales of approximately $2.7 billion in the US for the 12 months ended April 2017.

First Published: Tue, June 13 2017. 13:03 IST
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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

Ezetimibe tablet, which had annual US sales of $ 2.7 bn, is used to reduce high cholesterol levels
The US Food & Drug Administration has granted marketing approval for tablet (10 mg) to two Indian companies - and Ezetimibe, a generic version of Merck’s 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 (tablet 10 mg),” stated Sun Pharmaceutical in a press release.

In a separate statement, said, “Zydus has received the final approval from US FDA to market tablet (10 mg). It will be produced at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.”

As per IMS, tablet had annual sales of approximately $2.7 billion in the US for the 12 months ended April 2017.

image
Business Standard
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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

The US Food & Drug Administration has granted marketing approval for tablet (10 mg) to two Indian companies - and Ezetimibe, a generic version of Merck’s 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 (tablet 10 mg),” stated Sun Pharmaceutical in a press release.

In a separate statement, said, “Zydus has received the final approval from US FDA to market tablet (10 mg). It will be produced at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.”

As per IMS, tablet had annual sales of approximately $2.7 billion in the US for the 12 months ended April 2017.

image
Business Standard
177 22