The United States Food and Drug Administration (FDA) has approved the skin infection-fighting drug Dalvance (dalbavancin).
The medicine could be used to treat "acute bacterial skin and skin structure infections," (ABSSSI), an FDA news release reported.
These infections could be caused by bacteria such as Staphylococcus aureus and Streptococcus pyogenes, it would be administered intravenously.
The drug is the first Qualified Infectious Disease Product (QIDPP) to receive FDA approval. This is given to drugs that have antibacterial or anti fungal properties with potentially life-saving effects.
"Today's approval demonstrates the FDA's commitment to encouraging increased development and approval of new antibacterial drugs, providing physicians and patients with important new treatment options," Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in the news release.
The drug was given a priority review in order to gain QIDPP approval. This provided a review of the drug's potential application. Dalvance is entitled to five years of marketing exclusivity.
Two clinical trials were conducted in order to determine the safety and efficiency of the drug.
Researchers looked at 1,289 people suffering from ABSSSI. The participants were randomly assigned either Dalvance or vancomycin, which is another antibacterial drug. The study suggested that Dalvance was just as effective as vancomycin in treating ABSSSI.
The most common side effects seen in the trials were " nausea, headache and diarrhea," the news release reported. Delvance patients were shown to have more instances of elevation on their liver enzyme tests. The drug's label will include adjustments for patients with renal impairment.
"The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products," the news release reported.
