Lupin gets USFDA’s nod to market generic Fenofibrate Tablets

30 Dec 2011 Evaluate

Pharma Major Lupin has received US Food and Drug Administration (USFDA) nod to market generic Fenofibrate Tablets, a cholesterol lowering drug, in the American market. The company has got the approval to sell 48 mg and 145 mg of generic Fenofibrate tablets in the American market. However, the company did not revealed the possible launch date of the product.

Earlier Abbott, the innovator of the drug, had filed patent litigations against seven firms, out of which five including those against Lupin and Teva have been settled. Abbott sells the drug under Tricor brand.

Further, Lupin could launch its generic version as early as July next year.

Earlier in December, Lupin’s US subsidiary - Lupin Pharmaceuticals, Inc. (LPI) received tentative approval for its Duloxetine Hydrochloride Delayed-release (HCL DR) Capsules 20 mg, 30 mg and 60 mg from the United States Food and Drugs Administration (USFDA) for the company’s Abbreviated New Drug Application (ANDA) to market a generic version of Eli Lily & Company’s Cymbalta Delayed-release Capsules.

Lupin has a vibrant presence in the Indian pharmaceuticals market and has over the past several years made major strides in expanding its therapy portfolio. The company has a robust promotion and distribution setup along with a strong presence in various therapeutic areas, including the fast growing diabetes market.

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