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news.The FDA has given approval for Advancis Pharmaceutical to market Keflex, its antibiotic therapy for uncomplicated skin and skin structure infections, in two new strengths of 333mg and 750mg.
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The new Keflex (cephalexin) 750mg strength provides healthcare professionals a more convenient way to deliver a total daily dose of 1500mg per day, through the ability to use just two daily doses of the 750mg capsules.
Keflex is approved for adult dosages ranging from one to four grams per day in divided doses; however, the majority of prescriptions are written for cephalexin 500mg three times daily – totaling 1500mg per day.
“Receiving our first supplemental NDA approval is a very significant milestone for Advancis and we believe our new Keflex products will make a meaningful financial contribution to the Company in 2006 and 2007,” said Dr Edward Rudnic, president, and CEO of Advancis. “We are pleased to have the opportunity to bring physicians greater flexibility in their prescribing of a drug that many consider a standard of care for skin infections.”
Advancis expects to begin marketing the new Keflex strengths in July of 2006.
Advancis acquired the rights to manufacture, market, and sell Keflex in the US from Eli Lilly in July of 2004 for $11 million. Advancis' net Keflex sales in 2005 were $4.8 million.