Saturday 16 August 2014

FDA approves new antibiotic

A second new drug to treat methicillin-resistant Staphylococcus aureus (MRSA) has been approved under the U.S. Food and Drug Administration's (FDA) new fast-track incentive program.
The first of the new antibiotics released under the scheme is called Dalvance. This is an intravenous drug that can treat skin and soft tissue infections, and the launch was reported on by Digital JournalDalvance is intended to treat acute bacterial skin and skin structure infections.
News of the second medication was released at the end of June 2014. The drug is known as Sivextro or tedizolid phosphate. The antibiotic has been approved for intravenous or oral use to treat severe MRSA. According to U.S. News and Health Report, the drug was clinically tested in more than 1,300 adults with serious skin infections. Here Sivextro was found to be as effective as linezolid, an antibiotic currently in use that has a similar mechanism of action.

Both antibiotics were developed and approved through FDA’s new Generating Antibiotic Incentives Now (GAIN) program, which offers incentives such as extended exclusivity to manufacturers of new antibiotics.
Under this scheme, the New York Times reports that at least two antibiotics may soon follow. Cubist Pharmaceuticals, the manufacturers of Sivextro, have also reported that the FDA are reviewing ceftozolone, an antibiotic candidate that aims to treat complicated urinary tract and intra-abdominal infections. Second, a clinical trial by researchers at Duke University tested the antibiotic oritavancin to treat acute skin infections. The initial results appear encouraging.

Posted by Tim Sandle

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