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Allergan Gets FDA QIDP Designation And Fast Track Designation For ATM-AVI

Allergan plc (AGN) said that the U.S. Food and Drug Administration has granted Qualified Infectious Disease Product or QIDP Designation and Fast Track Designation for ATM-AVI or aztreonam and avibactam, for the treatment of complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), and hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP).

ATM-AVI is an investigational, fixed-dose, intravenous combination antibiotic under development globally.

ATM-AVI is being jointly developed with Pfizer. Allergan holds the rights to commercialize ATM-AVI in North America, while Pfizer holds the rights to commercialize this investigational therapy in the rest of the world.

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