New Delhi: Drug firm Zydus Cadila said it has received approval from the US health regulator to market ezetimibe tablets used to treat high cholesterol.
The company has received the final approval from the USFDA to market ezetimibe tablets USP, 10 mg, Zydus Cadila said in a BSE filing.
Ezetimibe is a drug used to reduce high cholesterol levels, the company said adding that it will be produced at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.
As per IMS MAT April 2017 data, the ezetimibe tablets have an estimated sales of USD 2.7 billion, it added.
The group now has around 115 approvals from USFDA and has so far filed 300 abbreviated new drug applications (ANDAs), the company said.