As announced recently by Advancis Pharmaceutical Corporation (Nasdaq: AVNC), the company’s supplemental NDA (new drug application) for additional Keflexâ (cephalexin capsules, USP) is still being reviewed by the USFDA.
"We were notified yesterday that the Agency has not yet completed their review of our application," said Edward M. Rudnic, Ph.D., president and CEO of Advancis. "However, we were informed that the FDA will be working to complete their review and we look forward to receiving the FDA's final action in the near future. We draw no negative inference from the notification and we continue to prepare for a launch of the products this July, assuming FDA approval."
Advancis Pharmaceutical Corporation is a pharmaceutical company focused on developing and commercializing novel anti-infective products and has acquired the rights to manufacture, market, and sell the Keflex brand of cephalexin in the United States in July of 2004.
Cephalexin, being the third most prescribed outpatient antibiotic in the United States has more than 25 million prescriptions written annually, making it the number-one most prescribed oral cephalosporin antibiotic and is also the number one recommended oral antibiotic therapy for uncomplicated skin and skin structure infections.
Source: Advancis Pharma Newsroom
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