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news.The FDA has indicated that Cubist Pharmaceuticals' application to expand the indication for its anti-infective drug Cubicin is approvable subject to the agency and the company reaching agreement on labeling for the drug.
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Cubicin is already approved for the treatment of complicated skin infections, but the company is now seeking approval for the drug as a treatment for S aureus bacteremia, an infection of the blood, and endocarditis, an associated inflammation of the lining of the heart’s cavities. The company was keen to point out that the FDA has not requested additional data.
Cubist said that it plans to respond to the approvable this week, which will commence a process to resolve the label negotiations within 60 days. The approvable letter follows the positive recommendations of the Anti-infective Drugs Advisory Committee (AIDAC) on March 6th.
“We will work towards achieving a label that accurately reflects the data from the company’s landmark trial, the patient population studied, as well as the guidance to the FDA from the AIDAC, which met less than three weeks ago,” said Cubist President and CEO, Mike Bonney.