Lupin’s arm gets USFDA approval for Generic Solodyn Tablets

02 Dec 2011 Evaluate

Pharma Major, Lupin’s US subsidiary - Lupin Pharmaceuticals, Inc. has received final approval for its Minocycline hydrochloride extended release tablets 45mg, 55mg, 90mg and 135mg strengths from the United States Food and Drugs Administration (USFDA) for the company’s abbreviated new drug application (ANDA) to market a generic version of Medicis Oharmaceutical Corporation’s Solodyn extended-release tablets.

Solodyn is an oral antibiotic approved to treat only the red, pus-filled pimples of moderate to serve acne in patients 12 years of age and older. Medicis’ Solodyn extended-release tablets had sales of $750 million September, 2011.

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. Lupin 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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