The FDA has approved a new antibiotic called Nuzyra (omadacycline) for adults with two types of infections: community-acquired bacterial pneumonia (a lung infection caught outside of a hospital) and acute bacterial skin and skin structure infections (serious skin infections). Nuzyra belongs to the tetracycline class of antibiotics and works by stopping bacteria from growing. It is available as an intravenous (IV) infusion or as oral tablets, giving doctors flexibility in treatment. This approval is important because it provides another weapon against antibiotic-resistant bacteria, including MRSA, which can cause hard-to-treat skin infections. However, like all antibiotics, Nuzyra should only be used when a bacterial infection is confirmed or strongly suspected. Using antibiotics when they are not needed can lead to more resistance. If you or a loved one has pneumonia or a serious skin infection, talk to your doctor about whether Nuzyra might be an option. This approval does not mean you should ask for this drug by name. Your doctor will decide the best treatment based on your specific infection, medical history, and test results. Always take antibiotics exactly as prescribed and finish the full course, even if you start feeling better.
FDA approved Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and ABSSSIFDA approved new antibiotic Nuzyra for pneumonia and skin infections.
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The FDA has approved Nuzyra (omadacycline), a new tetracycline-class antibacterial, for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). The approval provides an additional oral and intravenous option for these common infections, particularly in an era of rising antimicrobial resistance. Nuzyra is indicated for infections caused by susceptible microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA) in ABSSSI. The drug is available as both an intravenous formulation and oral tablets, with specific dosing regimens for each indication. To reduce the development of drug-resistant bacteria, Nuzyra should be used only for infections proven or strongly suspected to be caused by susceptible bacteria.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Nuzyra is a tetracycline class antibacterial. The specific mechanism of action is not detailed in the label.
Nuzyra is indicated for adult patients with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms including Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. It is also indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms including Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus group, Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.
For CABP: Loading dose on Day 1: either 200 mg IV over 60 minutes or 100 mg IV over 30 minutes twice, or 300 mg orally twice. Maintenance dose: 100 mg IV over 30 minutes once daily or 300 mg orally once daily. For ABSSSI: Loading dose on Day 1: either 200 mg IV over 60 minutes or 100 mg IV over 30 minutes twice, or 450 mg orally once daily on Days 1 and 2. Maintenance dose: 100 mg IV over 30 minutes once daily or 300 mg orally once daily. Treatment duration is 7 to 14 days. Oral tablets should be taken after fasting for at least 4 hours, with water only; no food or drink (except water) for 2 hours after dosing, and no dairy products, antacids, or multivitamins for 4 hours after dosing. No dosage adjustment is needed for renal or hepatic impairment.
Trial data not available in label.
Not reported in label.
Nuzyra provides an additional treatment option for CABP and ABSSSI in adults, including coverage of MRSA in ABSSSI. Its oral and IV formulations allow for step-down therapy. Use should be guided by susceptibility data to minimize resistance development.
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