government
FDA chooses antibiotic for fast-track review
NEWS IN BRIEF — Posted Oct. 1, 2012
The Food and Drug Administration has designated an antibiotic for treating lung and skin infections as one of the first medications to undergo a new fast-track review process authorized by a federal law in July.
The qualified infectious disease product designation was given to delafloxacin, manufactured by Rib-X Pharmaceuticals, officials said in a Sept. 17 announcement. The expedited FDA review was created by the bipartisan Generating Antibiotic Incentives Now Act, which was enacted as part of a comprehensive drug safety and innovation reauthorization bill signed by President Obama on July 9.
Delafloxacin is being developed as a first-line antibiotic to be used in hospitals for drug-resistant infections, the New Haven, Conn.-based Rib-X said in a statement. The designation under the law would give the company an additional five years of market exclusivity and priority review.
“Fast-tracking drugs like delafloxacin will help decrease the risk of a nationwide, drug-resistant epidemic,” said Rep. Phil Gingrey, MD (R, Ga.), who sponsored the legislation authorizing the process. “As a physician for more than 30 years, I understand the critical need for new medical treatments. Because of the GAIN Act, today marks the first step in that direction. I look forward to the research and development of more drug-resistant antibiotics.”
Note: This item originally appeared at http://www.ama-assn.org/amednews/2012/10/01/gvbf1001.htm.
