Vibativ Receives New Indication
May 6, 2016 – The U.S. Food and Drug Administration (FDA) approved a new indication for Vibativ® (telavancin), an antibacterial drug manufactured by Theravance Biopharma. It is now indication for S. aureus bacteremia (S. aureus bacteria in the blood) among patients using it for one of its other indications. Vibativ was originally was approved in 2009 to treat adult patients who have complicated skin and skin structure infections. In 2013, Vibativ was approved as an alternative to vancomycin for treating hospital-acquired or ventilator-associated pneumonia that is caused by Staphylococcus aureus (S. aureus) and that does not respond to other antibacterial drugs. A boxed warning on its label cautions that it should not be administered to patients who have decreased kidney function or to women who are pregnant.
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.