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FDA clears Actavis combo antibiotic

Feb. 25, 2015 5:34 PM ETAllergan plc (AGN) StockAGN, AZNBy: Douglas W. House, SA News Editor
  • The FDA approves Forest Laboratories subsidiary Forest Pharmaceuticals' (NASDAQ:ACT) Avycaz (ceftazidime-avibactam) for the treatment of adult patients with complicated intra-abdominal infections, in combination with metronidazole, and complicated urinary tract infections, including kidney infections, who have limited or no alternative treatment options.
  • Avycaz contains ceftazidime, a previously approved cephalosporin antibacterial drug and avibactam, a non-beta lactam beta-lactamase inhibitor antibiotic to extend bacterial resistance. The addition of avibactam protects ceftazidime from being broken down by beta-lactamases that are produced by resistant bacteria.
  • Avycaz is a Qualified Infectious Disease Product (QIDP) which adds a five-year period of market exclusivity to the five-year exclusivity period provided under the Food, Drug and Cosmetic Act. It is the fifth QIDP-tagged drug cleared by the FDA.
  • The product was developed under a collaboration between Forest Labs and AstraZeneca (NYSE:AZN).

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