ADVANCIS GETS FDA APPROVABLE LETTER FOR KEFLEX

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Advancis has announced that the FDA has issued an approvable letter in response to the company's supplemental new drug application (NDA) for two new strengths of the antibiotic Keflex (cephalexin capsules). Advancis received approval to market 333 mg and 750 mg capsules.

The new Keflex (cephalexin) 750 mg strength provides healthcare professionals a more convenient way to deliver a total daily dose of 1500 mg per day, through the ability to use just two daily doses of the 750 mg 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 500 mg three times daily -- totaling 1500 mg per day.