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Kimyrsa FDA Approval History

Last updated by Judith Stewart, BPharm on April 1, 2021.

FDA Approved: Yes (First approved March 12, 2021)
Brand name: Kimyrsa
Generic name: oritavancin
Dosage form: for Injection
Company: Melinta Therapeutics
Treatment for: Skin and Structure Infection

Kimyrsa (oritavancin) is a lipoglycopeptide antibiotic for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSI) caused by designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA).

  • Kimyrsa is a long-acting, single-dose antibiotic administered by intravenous infusion over 1 hour.
  • Kimyrsa is the second oritavancin product to be approved by the FDA after the approval of Orbactiv in 2014. Orbactiv is administered as a single-dose intravenous infusion over 3 hours.
  • Common adverse reactions in people treated with oritavancin include headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.

Development Timeline for Kimyrsa

Mar 15, 2021Approval  FDA Approves Kimyrsa (oritavancin) for the Treatment of Adult Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Further information

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