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Cipla gets USFDA nod for lipid regulating 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 BSE filing

Cipla gets USFDA nod for lipid regulating tablets
The government is learnt to have told the Supreme Court that drugmakers have not followed proper licensing procedures and clearances.

Drug firm Cipla has received final approval from the US health regulator 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 BSE filing.

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

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“Tricor tablets and generic equivalents had US sales of approximately USD 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. Shares of Cipla were trading 0.76 per cent up at Rs 570.30 on BSE.

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