Chicago-based Durata Therapeutics, Inc. (Nasdaq:DRTX) has announced that the US FDA has approved the sale and distribution of its new antibiotic for the treatment of common bacterial skin infections which are acquired in the hospitals. The antibiotic which is administered intravenously is manufactured by Chicago-based Durata Therapeutics, Inc. (Nasdaq:DRTX) and is named Dalvance. It is recommended for treatment of acute bacterial infection of the skin and dermal regions.
Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research in a press statement said that with the approval of Dalvance, the FDA is fulfilling its pledge of encouraging the development of antibacterial drugs which is important in providing both clinicians and patients with required variety of treatment options.
Dalvance will become the first Qualified Infectious Disease Product (QIDP) to receive FDA approval. Dalvance is a human anti bacterial drug which will be very useful in treatment of life threatening infections and hence the FDA supported the QIDP designation of Dalvance. Trials conducted on 1300 adults with ABSSI and half were treated with Dalvance while the rest were treated with Vancomycin. Both the groups benefitted equally from both the drugs.
The new drug is not devoid of side effects like headaches, nausea and diarrhea and also elevated readings in one of their liver enzyme test.