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Dalbavancin is the first drug with a Qualified Infectious Disease Product designation to be approved by the Food and Drug Administration.
On May 23, the agency approved dalbavancin (Dalvance) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus. The drug, which is given intravenously, is effective for methicillin-susceptible and methicillin-resistant strains as well as Streptococcus pyogenes.
Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, dalbavancin was granted Qualified Infectious Disease Product designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections, according to a statement issued by the FDA.
As part of its QIDP designation, dalbavancin was given priority review and qualifies for an additional 5 years of marketing exclusivity, in addition to the exclusivity period already provided by the Food, Drug and Cosmetic Act.
Dalbavancin was shown to be as safe and effective as vancomycin for the treatment of ABSSSI in two clinical trials with a total of 1,289 adults who had ABSSSI and were randomly assigned to one of the two drugs.
The most common side effects identified in the clinical trials were nausea, headache and diarrhea. More participants in the dalbavancin group had elevated liver enzymes.
Dalvance is marketed by Durata Therapeutics.
Dalbavancin is the first drug with a Qualified Infectious Disease Product designation to be approved by the Food and Drug Administration.
On May 23, the agency approved dalbavancin (Dalvance) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus. The drug, which is given intravenously, is effective for methicillin-susceptible and methicillin-resistant strains as well as Streptococcus pyogenes.
Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, dalbavancin was granted Qualified Infectious Disease Product designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections, according to a statement issued by the FDA.
As part of its QIDP designation, dalbavancin was given priority review and qualifies for an additional 5 years of marketing exclusivity, in addition to the exclusivity period already provided by the Food, Drug and Cosmetic Act.
Dalbavancin was shown to be as safe and effective as vancomycin for the treatment of ABSSSI in two clinical trials with a total of 1,289 adults who had ABSSSI and were randomly assigned to one of the two drugs.
The most common side effects identified in the clinical trials were nausea, headache and diarrhea. More participants in the dalbavancin group had elevated liver enzymes.
Dalvance is marketed by Durata Therapeutics.
Dalbavancin is the first drug with a Qualified Infectious Disease Product designation to be approved by the Food and Drug Administration.
On May 23, the agency approved dalbavancin (Dalvance) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus. The drug, which is given intravenously, is effective for methicillin-susceptible and methicillin-resistant strains as well as Streptococcus pyogenes.
Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, dalbavancin was granted Qualified Infectious Disease Product designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections, according to a statement issued by the FDA.
As part of its QIDP designation, dalbavancin was given priority review and qualifies for an additional 5 years of marketing exclusivity, in addition to the exclusivity period already provided by the Food, Drug and Cosmetic Act.
Dalbavancin was shown to be as safe and effective as vancomycin for the treatment of ABSSSI in two clinical trials with a total of 1,289 adults who had ABSSSI and were randomly assigned to one of the two drugs.
The most common side effects identified in the clinical trials were nausea, headache and diarrhea. More participants in the dalbavancin group had elevated liver enzymes.
Dalvance is marketed by Durata Therapeutics.
