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FDA approves Cubist's Zerbaxa

December 20, 2014 3:14 AM UTC

FDA approved Zerbaxa ceftolozane/tazobactam from Cubist Pharmaceuticals Inc. (NASDAQ:CBST) to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).

Zerbaxa was under Priority Review after receiving Qualified Infectious Disease Product designation under the Generating Antibiotic Incentives Now (GAIN) Act to treat Gram-negative bacteria. QIDP qualifies the drug for an additional five years of marketing exclusivity. ...