The FDA panel has approved Actavis drug for treating severe infections caused by the drug resistant pathogens

SHAFAQNA – Actavis has sent a new investigational antibiotic to be considered for approval by the US Food and Drug Administration. The drug, named ceftazidime-avibactam, is aimed at helping to treat hospitalized patients with uniquely complicated intra-abdominal and complicated urinary tract infections caused by the drug resistant pathogens. This treatment is actually a combination of other drugs that could address very serious or even life-threatening infections which the medical industry has not been able to meet.

And advisory panel for the US Food and Drug Administration (FDA) has announced that they are fully in support of this drug and will recommend it for approval to the FDA.

The committee took the decision after the clinical and scientific trials showed promising result to treat the complicated bacterial infections.

David Nicholson, Senior Vice President of Global Brands Research and Development for Actavis, comments “We are pleased with the committee’s positive recommendation for ceftazidime-avibactam. It reinforces our belief in the safety and efficacy of the compound and its potential to address significant unmet needs as a new treatment option for patients with serious and life-threatening infections.

As public health officials continue to sound the alarm on antibiotic-resistant infections, Actavis remains committed to advancing the ceftazidime-avibactam clinical development program, including for the combination of hospital acquired bacterial pneumonia (HABP)/ ventilator-associated bacterial pneumonia (VABP) and bacteremia, and working closely with the FDA as it completes its review of our New Drug Application.”

More specifically, the new treatment is still an investigational antibiotic that Actavis has specifically designed to treat serious cIAI and cUTI caused by gram-negative bacteria, which are resistant to many drugs as well as commonly available antibiotics as well. The treatment is made up of ceftazidime, avibactam, and antipseudomonal cephalosporin.

However the panel had still some doubts about the of the product, and the committee voted to not suggest the drug in treating hospitalized patients with bacteremia, hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).

The panel, which only advises the FDA, does not have any legal implications behind its decisions, so the FDA can still opt to not approve the New Drug Application, which they will deliberate about until sometime in the next few months.

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