Posted in Flagyl on February 28, 2015

The Food and Drug Administration (FDA) has approved Avycaz (ceftazidime-avibactam), a just discovered antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in amalgamation with metronidazole, and complicated urinary homily infections (cUTI), including kidney infections (pyelonephritis), who accept limited or no alternative treatment options. 

Avycaz is a fixed-coalition drug containing ceftazidime, a previously approved cephalosporin antibacterial remedy, and avibactam, a new beta-lactamase inhibitor.

“The FDA is committed to make therapies available to treat patients with unmet medical need,” says Edward Cox, MD, MPH, mentor of the Office of Antimicrobial Products in the FDA’s Center with respect to Drug Evaluation and Research. “It is weighty that the use of Avycaz have existence reserved to situations when there are limited or ~t any alternative antibacterial drugs for treating a patient’s pest.”

Avycaz is the fifth approved antibacterial medicine product designated as a Qualified Infectious Disease Product (QIDP). This pointing out is given to antibacterial products to entertainment serious or life-threatening infections in the Generating Antibiotic Incentives Now (GAIN) denominate of the FDA Safety and Innovation Act.

As piece of its QIDP designation, Avycaz was given precedence review, which provides an expedited re-survey of the drug’s application. The QIDP selection also qualifies Avycaz for an additional five years of marketing exclusivity to have existence added to the five-year exclusivity conclusion provided by the Food, Drug, and Cosmetic Act. 

The ascertainment of efficacy of Avycaz was supported in concern by the findings of the competency and safety of ceftazidime for the management of cIAI and cUTI. The grant of avibactam to Avycaz was based ~ward data from in vitro studies and creature models of infection. Avycaz was wilful in two Phase 2 trials, one each in cIAI and cUTI. Both trials were not designed with any formal hypotheses for inferential testing opposed to the active comparators.

The most threadbare side effects include vomiting, nausea, constipation and anxiety. Health care professionals should advise patients of these risks and furthermore advise that decreased efficacy, seizures and other neurologic events were seen in patients by poor kidney function (renal impairment). Serious hide reactions and anaphylaxis may occur in patients with penicillin allergies.

Avycaz is distributed ~ means of Forest Pharmaceuticals Inc., a subsidiary of Forest Laboratories Inc. based in Cincinnati, Ohio.

Source: FDA

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