FDA Approved New Antibacterial Infusion
February 25, 2015 – The U.S. Food and Drug Administration (FDA) approved Avycaz (ceftazidime / avibactam for injection). Avycaz, manufactured by Actavis, is a new antibacterial drug treatment for adults who have few or no other options for controlling certain complicated infections. Avycaz is indicated for the treatment of complicated urinary tract infections and it is also approved for use, in combination with metronidazole, to treat complicated intra-abdominal infections.
Avycaz combines ceftazidime, an injectable third-generation cephalosporin currently available on the market, and avibactam, a new beta-lactamase inhibitor that that blocks enzymes that break down ceftazidime. Avycaz is given as a two-hour infusion every eight hours for patients with normal kidney function. Actavis plans to release Avycaz in the second quarter of 2015.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.