FDA Approves Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and ABSSSI

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FDA Published May 19, 2026 Medically reviewed May 19, 2026 DOI ↗ By Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

Key Takeaway

Consider Nuzyra as a treatment option for CABP and ABSSSI in adults, including MRSA coverage for skin infections.

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)

Mechanism of Action

Nuzyra is a tetracycline class antibacterial. The specific mechanism of action is not detailed in the label.

Indication & Patient Population

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.

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

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.

Study Details

Study typeFda approval

PublishedOct 2018

View Original Abstract ↓

1 INDICATIONS AND USAGE NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms ( 1 ): Community-acquired bacterial pneumonia (CABP) ( 1.1 ) Acute bacterial skin and skin structure infections (ABSSSI) ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.3 ) 1.1 Community-Acquired Bacterial Pneumonia (CABP) NUZYRA is indicated for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae , Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae , Haemophilus parainfluenzae , Klebsiella pneumoniae, Legionella pneumophila , Mycoplasma pneumoniae, and Chlamydophila pneumoniae . 1.2 Acute Bacterial Skin and Skin Structure Infections (ABSSSI) NUZYRA is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis , Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus , S. intermedius , and S. constellatus ), Enterococcus faecalis , Enterobacter cloacae, and Klebsiella pneumoniae. 1.3 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.