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Nuzyra FDA Approval History

Reviewed by J.Stewart B.Pharm. Last updated on Oct 29, 2018.

FDA Approved: Yes (First approved October 2, 2018)
Brand name: Nuzyra
Generic name: omadacycline
Dosage form: for Injection and Tablets
Company: Paratek Pharmaceuticals, Inc.
Treatment for: Skin and Structure Infection, Pneumonia

Nuzyra (omadacycline) is an aminomethylcycline tetracycline antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

Antibacterial Resistance
Patients should be advised that antibacterial drugs including Nuzyra should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Nuzyra is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by Nuzyra or other antibacterial drugs in the future.

Administration with Food
Patients are advised to fast 4 hours before and 2 hours after taking Nuzyra tablets and not to consume dairy products, antacids, or multivitamins for 4 hours after taking Nuzyra tablets.

Allergic Reactions
Patients are advised that allergic reactions, including serious allergic reactions, could occur and that serious allergic reactions require immediate treatment. Patients should be asked about any previous hypersensitivity reactions to Nuzyra, or other tetracycline class antibacterials.

Tooth Discoloration and Inhibition of Bone Growth
Patients are advised that Nuzyra, like other tetracycline-class drugs, may cause permanent tooth discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy. Tell your healthcare provider right away if you become pregnant during treatment.

Patients are advised that diarrhea is a common problem caused by antibacterial drugs, including Nuzyra, which usually ends when the antibacterial drugs is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery or bloody stools (with or without stomach cramps and fever). If this occurs, patients should contact their physician as soon as possible.

Nausea and Vomiting
Patients are advised that nausea and vomiting can be an adverse reaction to Nuzyra. A greater proportion of patients who received the oral loading dose of Nuzyra for treatment of ABSSSI experienced nausea and vomiting.

Women are advised not to breastfeed during treatment with Nuzyra and for 4 days after the last dose.

Adverse Reactions
The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.

Development Timeline for Nuzyra

Oct  2, 2018Approval FDA Approves Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and Acute Skin and Skin Structure Infections
Aug  8, 2018FDA Advisory Committee Recommends Approval of Paratek’s Omadacycline
Jun 11, 2018Paratek Presents New Analysis from Combined Phase 3 Skin Infection Studies Highlighting Efficacy of Omadacycline in Treating Drug Resistant S. aureus
Apr  4, 2018Paratek’s New Drug Applications for Oral and Intravenous Omadacycline Accepted for Priority Review by FDA
Feb  5, 2018Paratek Completes Submission of New Drug Applications to U.S. FDA for Oral and Intravenous Omadacycline for Pneumonia and Skin Infections

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.