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
Further information
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