Dalvance New Dosing Regimen
January 20, 2016 – The U.S. Food and Drug Administration (FDA) approved Dalvance (dalbavancin) to be administered as one dose of 1,500mg over 30 minutes with no follow-up dose. Dalvance is manufactured by Allergan and originally gained approval in May 2014 for treating adults with acute bacterial skin and skin structure infections (ABSSSI) that are caused by specific bacteria. Dalvance is one of the few antibiotics effective to treat methicillin-resistant Staphylococcus aureus (MRSA). Original dosing was one 1,000mg intravenous (IV) infusion administered over a 30-minute period and followed after one week by a second infusion of 500mg.
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.