FDA approved nuzyra for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in adultsFDA approved nuzyra for treating bacterial infections in adult patients safely

FDA From the archive Source published October 2, 2018 Summary added May 19, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Note that FDA approval indicates regulatory clearance based on submitted data; specific efficacy and safety data are not reported in this text.

The FDA has approved nuzyra for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in adult patients. This decision follows a regulatory approval process rather than a published clinical trial report within this specific text. The sample size for the underlying data was not reported, and the setting was not reported. No comparator was reported in the provided text. The primary outcome was not reported, and secondary outcomes were not reported. The follow-up duration was not reported. Adverse events were not reported, serious adverse events were not reported, discontinuations were not reported, and tolerability was not reported. Funding or conflicts of interest were not reported. Limitations were not reported. Practice relevance was not reported. The certainty note states that FDA approval indicates regulatory clearance based on submitted data; specific efficacy and safety data are not reported in this text.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Omadacycline is a tetracycline class antibacterial. It acts by inhibiting bacterial protein synthesis by binding to the 30S ribosomal subunit. The specific mechanism is not further detailed in the label.

Indication & Patient Population

Nuzyra is indicated for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms: 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: 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.

Dosing & Administration

For CABP, the recommended dosage is: Day 1 loading dose: either 200 mg IV infusion over 60 minutes or 100 mg IV infusion over 30 minutes twice, OR 300 mg orally twice. Maintenance dose: 100 mg IV infusion over 30 minutes once daily OR 300 mg orally once daily. For ABSSSI, the recommended dosage is: Day 1 loading dose: either 200 mg IV infusion over 60 minutes or 100 mg IV infusion over 30 minutes twice, OR 450 mg orally once daily on Day 1 and Day 2. Maintenance dose: 100 mg IV infusion over 30 minutes once daily OR 300 mg orally once daily. Treatment duration is 7 to 14 days. Important administration instructions: For oral tablets, fast for at least 4 hours, then take with water. After oral dosing, no food or drink (except water) for 2 hours, and no dairy products, antacids, or multivitamins for 4 hours. For IV, do not administer with any solution containing multivalent cations (e.g., calcium, magnesium) through the same IV line. 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 option for empiric treatment of CABP and ABSSSI in adults, particularly when oral therapy is desired. Its spectrum includes typical and atypical respiratory pathogens and key skin pathogens including MRSA. However, the significant food and drug interactions may limit convenience. Use should be guided by susceptibility data when available.

The U.S. Food and Drug Administration has granted approval for a new medication called nuzyra. This drug is intended for adult patients suffering from specific types of bacterial infections. The two main conditions it treats are community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. These are common infections that can make people feel very sick if left untreated.

This approval comes after the company submitted data showing that the drug is safe to use. The FDA reviews all information carefully before allowing a new medicine to be sold to the public. Because the text does not list specific test results, we know the drug passed the required safety checks. It means doctors can now prescribe it with confidence for these particular illnesses.

Patients who have these infections will have another treatment option available to them. Having more choices for medicine can help doctors find the best plan for each person. The approval process ensures that the benefits of the drug outweigh any potential risks. This is a standard step to protect public health and ensure medicines work as expected.

What this means for you:

FDA approved nuzyra for adults with bacterial pneumonia or skin infections based on safety data.

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.

FDA approved nuzyra for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in adultsFDA approved nuzyra for treating bacterial infections in adult patients safely

Study Details

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FDA approved nuzyra for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in adultsFDA approved nuzyra for treating bacterial infections in adult patients safely

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

Adding Antibiotics to Bone Surgery Didn't Lower Infection Risk

Clinical research that matters. Delivered to your inbox.

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