New Fluoroquinolone Antibiotic Approved
June 19, 2017 – The U.S. FDA has approved Baxdela™ (delafloxacin), manufactured by Melinta Therapeutics, for the treatment of adults who have acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive and gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Available as both oral tablets and intravenous (IV) infusions, Baxdela is dosed at 12 hour intervals for a minimum of five days, and up to a maximum of 14 days. One 450mg tablet is equivalent to and interchangeable with one 300mg infusion.
All fluoroquinolone antibiotics have the potential to cause tendonitis or tendon ruptures, peripheral neuropathy and central nervous system (CNS) reactions ranging from dizziness to toxic psychosis. Fluoroquinolone antibiotics carry a black box warning to alert patients to the risks, and to caution against the use of fluoroquinolone antibiotics for patients who have myasthenia gravis.
Baxdela is the first FDA-approved drug for Melinta Therapeutics. Pricing plans and a projected launch date are 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.