New Dosage Form Approved for Vancomycin

January 29, 2018 – The U.S. FDA has approved Firvanq™ (vancomycin) oral solution, manufactured by CutisPharma, Inc. It is the first oral solution dosage form of vancomycin, an antibiotic that has been available in other forms since the 1960s. Firvanq is approved for the treatment of diarrhea caused by Clostridium difficile, and enterocolitis (inflammation of the small intestine and colon) caused by Staphylococcus aureus enterocolitis.

Due to concerns regarding the emergence of vancomycin-resistant Enterococcus species of bacteria, vancomycin is typically reserved to treat serious Gram-positive infections resistant to certain other antibiotics, including methicillin. Firvanq should not be used to treat infections other than those included in its specific indications. Recommended dosing varies based on the age of the patient and the indication.

Firvanq will be available in kits containing a grape-flavored diluent and vancomycin hydrochloride USP, powder for oral solution equivalent to 3.75 g, 7.5 g, 10.5 g or 15 g vancomycin. Launch is planned for April of 2018. Pricing is not yet available.

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 U.S. mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• U.S. 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 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.