Advancis to sell 333 mg, 750 mg capsules of antibiotic Keflex

By Elaine Rigoli

Tampa, Fla., May 15 -The Food and Drug Administration has issued an approval letter in response to Advancis Pharmaceutical Corp.'s supplemental New Drug Application to market the 333 mg and 750 mg capsules of antibiotic Keflex (cephalexin capsules, USP).

"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," president and chief executive officer Edward M. Rudnic said in a news release.

Advancis expects to begin marketing the new Keflex strengths nationwide with a targeted sales force of about 75 sales representatives beginning in July.

Cephalexin is the third most prescribed outpatient antibiotic in the United States with more than 25 million prescriptions written annually, the release said.

Advancis' net Keflex sales in 2005 were $4.8 million.

The company also announced that it was on schedule to complete its ongoing phase 3 trial of amoxicillin Pulsys for adolescents and adults with pharyngitis/tonsillitis by the end of this cold/flu season. Trial results will be released in the third quarter of 2006.

Advancis, based in Germantown, Md., is a pharmaceutical company focused on the development and commercialization of pulsatile drug products that fulfill substantial unmet medical needs in the treatment of infectious disease.

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