Cipla gets US regulator’s nod for lipid regulating tablets

19/12/2016 17:10

Drug firm Cipla has received final approval from the US health regulator – US Food and Drug Administration (FDA) – for lipid regulating Fenofibrate tablets.

The company “has received final approval for its abbreviated new drug application (ANDA) for Fenofibrate tablets USP 48mg and 145mg, from the United States Food and Drug Administration (USFDA),” Cipla said in a filing to the BSE.

The tablets are generic versions of AbbVie’s Tricor tablets, it added.

“Tricor tablets and generic equivalents had US sales of approximately $307 million for the 12-month period ending October 2016, according to IMS Health,” Cipla said.

The company’s portfolio includes over 1,000 products across a wide range of therapeutic categories.


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