FDA sanctions the use of Actavis Antibiotic for drug-resistant pathogens

Manufactured as a joint-venture between AstraZeneca and Actavis, two British-Sweden pharmaceutical companies, Actavis Antibiotic has been approved by the US Food and Drugs Administration (FDA) for the treatment of intra-abdominal infections (cUTI) and urinary tract infections (cIAI) occasioned by drug-resistant pathogens.

Actavis Antibiotic was approved after its Phase II trial showed promises of effectiveness and safety for patients suffering from cIAI and cUTI. The FDA had scrutinized submitted reports for clinical trials and given a limited approval that the drug be used only for the treatment of cIAI and cUTI.

Also known as ceftazidime-avibactam, Actavis Antibiotic was not approved by the FDA for the treatment of hospital-acquired bacterial pneumonia HABP, ventilator associated bacterial pneumonia VABP, and bacteremia. It was also not approved for the treatment of renal impairments among other infections because clinical trials for other infections were not satisfactory.

AstraZeneca and Actavis, the drug manufacturer hopes to continue with clinical trials so that the FDA might approve it for the treatment of other infections in time to come, and David Nicholson, Actavis Global Brands Research and Development Senior Vice President, adds, “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 the combination of hospital-acquired bacterial pneumonia (HABP) / ventilator-associated bacterial pneumonia (VABP) and bacteremium.”

Since it is hoped that FDA might allow for the marketing of the drug next year, it is not yet approved for general distribution until the regulatory agency agrees that the antibiotic be so distributed. Furthermore, the drug company Actavis owns the right for the medication in North America and the second company AstraZeneca holds the rights everywhere else globally.