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
| Date | Article |
|---|---|
| Mar 15, 2021 | Approval 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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