June 20 The U.S. Food and Drug Administration said on Friday it approved a new drug to treat acute bacterial skin infections made by Cubist Pharmaceuticals Inc.
The drug, Sivextro, is designed to treat serious acute bacterial skin and skin structure infections, or ABSSSI. These are infections that involve deep tissue or are associated with an underlying disease such as diabetes.
Approval of Sivextro, known also as tedizolid, follows on the heels of the FDA's approval of a drug for the same condition made by Durata Therapeutics Inc known as Dalvance, or dalbavancin.
The drugs target Gram-positive infections, including methicillin-resistant Staphylococcus aureus, or MRSA. Sivextro is given once daily for six days. Dalvance is given in two doses, eight days apart.
"MRSA is still problematic in the U.S. and is responsible for the deaths of more than 11,000 Americans each year," Dr. Ralph Corey, professor of medicine and infectious disease at Duke University Medical Center, said in a statement. "Not every antibiotic will work for every patient and more drug options are an imperative."
The main treatment for MRSA is vancomycin, which is available generically.
Sivextro received an expedited review by the FDA and was designated a qualified infectious disease product, meaning it qualifies for an extra five years of marketing exclusivity.
The most common side effects of the drug were nausea, headache, diarrhea, vomiting and dizziness.
(Reporting by Toni Clarke in Washington; Editing by Leslie Adler)
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