This is an antibiotic obviously that can help fight off infections such as MRSA and Strep viruses. It is given in two doses. It is designated as an infectious disease product.
It’s a 5 year old company with no revenue so far and this is the first company drug approved. It acquired the rights to the drug from Pfizer in 2009. The full press release can be read here. BD
Chicago-based Durata Therapeutics Inc. said Friday that the U.S. Food and Drug Administration approved its first drug, a once-weekly intravenous antibiotic aimed at acute bacterial skin infections and skin structure infections.
The drug, dalbavancin, will be marketed as Dalvance and was approved to treat adults who have deep-tissue infections or skin problems associated with underlying diseases like diabetes.
It is aimed at treating serious bacterial infections, including Streptococcus and methicillin-resistant Staphylococcus aureus, or MRSA, and is administered in two doses.
Durata said the drug was is the first drug with the qualified infectious disease product designation to gain FDA approval.