European regulators will review a Cubist Pharmaceuticals Inc. application to sell a new antibiotic treating urinary tract and intra-abdominal infections in the European Union.
The biotech company, based in Lexington, said Friday that its experimental antibiotic, called ceftolozane/tazobactam, has been accepted for review by the European Medicines Agency, an arm of the European Commission that rules on new drug applications. Cubist is expecting a decision next year on the drug, which fights infections caused by Gram-negative bacteria.
Cubist has also applied for approval of ceftolozane/tazobactam by the Food and Drug Administration and is expecting the US regulatory agency to make a ruling by Dec. 21.
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