December 6, 2014 / 12:30 AM / 5 years ago

FDA panel recommends approval for Actavis' antibiotic drug

(Reuters) - Actavis Plc said a panel advising the United States Food and Drug Administration recommended the approval of its antibiotic to treat two infections caused by drug-resistant bacteria.

The drug, ceftazidime-avibactam, is safe and effective to treat intra-abdominal infections (cIAI) and urinary tract infections (cUTI), when limited or no alternative treatments are available, the anti-infective advisory committee said on Friday.

The panel, however, raised concerns around labeling, particularly for patients with renal impairment, Sanford Bernstein & Co analyst Aaron Gal wrote in a note.

The committee also voted not to recommend the drug’s use in treating hospital-acquired bacterial pneumonia (HABP) and bacteremia, citing inadequate evidence.

Dublin, Ireland-based Actavis said it intends to continue testing the drug to generate more data.

While the FDA is not obligated to accept the panel’s recommendations, it typically does so.

The company said it expects the regulator to give its final decision on the drug in the first quarter of 2015.

Bernstein’s Gal said he expects the drug to generate as much as $170 million in sales annually.

Ceftazidime-avibactam is being co-developed with British drugmaker AstraZeneca Plc. Actavis holds the rights to market it in North America, while AstraZeneca has rights for the rest of the world.

Reporting by Natalie Grover in Bengaluru; Editing by Siddharth Cavale

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