Labeling Extended for Avycaz
June 22, 2016 – The U.S. FDA approved a request by Allergan to add information from a Phase III study to the labeling for Avycaz® (ceftazidime/avibactam). Avycaz is an intravenous (IV) drug that includes two kinds of antibacterials; one is a cephalosporin and one a beta-lactamase inhibitor. Avycaz received FDA approval, in combination with metronidazole, to treat patients with complicated intra-abdominal infections that also are due to specific microorganisms. Following the FDA’s approval, Avycaz labeling now can include information about its effectiveness against more types of bacteria that cause complicated intra-abdominal infections.
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.