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Nuzyra FDA Approval History

Last updated by Judith Stewart, BPharm on June 8, 2021.

FDA Approved: Yes (First approved October 2, 2018)
Brand name: Nuzyra
Generic name: omadacycline
Dosage form: Tablets and Lyophilized Powder for Injection
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).

  • Nuzyra is a modernized tetracycline specifically designed to overcome tetracycline resistance. It exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.
  • Nuzyra is administered via intravenous infusion or oral tablets.
  • Nuzyra tablets should be taken on an empty stomach (patients need to fast for 4 hours before and 2 hours after taking Nuzyra tablets) and must not consume dairy products, antacids, or certain multivitamins for 4 hours after taking Nuzyra tablets.
  • Nuzyra may cause serious adverse reactions including hypersensitivity reactions, tooth discoloration, Clostridioides difficile-associated diarrhea, and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy.
  • Common adverse reactions include 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

Jun  1, 2021Approval Paratek Pharmaceuticals Announces FDA Approval of Nuzyra (omadacycline) Oral Only Dosing Regimen for the Treatment of Community-Acquired Bacterial Pneumonia (CABP)
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
Jul 17, 2017Paratek Announces Phase 3 Study of Oral-Only Dosing of Omadacycline Met All Primary and Secondary FDA and EMA Efficacy Endpoints in Acute Bacterial Skin Infections

Further information

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