FDA Accepts Actavis’ NDA for Combination Antibiotic

Actavis plc reports that the US Food and Drug Administration (FDA) has accepted for filing Actavis’ application for ceftazidime-avibactam, an investigational antibiotic being developed to treat serious Gram-negative bacterial infections. It consists of ceftazidime, a third-generation, antipseudomonal cephalosporin, that is an established and respected treatment for serious Gram-negative bacterial infections, and avibactam, a next generation, non-β lactam β-lactamase inhibitor.

As agreed with the FDA, ceftazidime-avibactam was submitted as a 505(b)(2) new drug application for complicated urinary tract Infections (cUTI) and complicated intra-abdominal Infections (cIAI), including those caused by multi-drug resistant Gram-negative bacterial pathogens. The FDA action date for ceftazidime-avibactam under the Prescription Drug User Fee Act (PDUFA) is expected during the first quarter of 2015.

On August 19, 2014, Actavis announced positive topline results from the single pooled dataset of RECLAIM-1 and -2, pivotal Phase III studies evaluating the potential for ceftazidime-avibactam as a treatment for adult patients with cIAI. The company intends to submit the results of the Phase III studies to the FDA as a supplemental NDA.

The FDA granted ceftazidime-avibactam Qualified Infectious Disease Product (QIDP) status for its indications of cIAI, cUTI, and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) on March 11, 2013.  The QIDP designation provides certain incentives for the development of new antibiotics, including priority review, eligibility for the FDA’s fast track program, and a five-year extension of exclusivity under the Hatch-Waxman Act.

Source: Actavis


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