New Antibacterial Drug Approved
August 29, 2017 – The U.S. FDA has approved Vabomere™ (meropenem/vaborbactam) injection, manufactured by Rempex, a subsidiary of The Medicines Company. Vabomere is indicated to treat adults who have complicated urinary tract infections (cUTI)—including a type of kidney infection, pyelonephritis—caused by specific types of bacteria. It contains a previously approved antibiotic (meropenem) with a new type of beta-lactamase inhibitor (vaborbactam), and is manufactured as an intravenous formulation.
Vabomere was designated a qualified infectious disease product (QIDP) by the FDA; QIDPs treat serious bacterial or fungal infections, including those resistant to other anti-infective therapies. The recommended dosing is 4gm delivered in a three-hour infusion once every eight hours, for a maximum of two weeks.
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.