Skip to Content

Nuzyra Approval History

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).

Development History and FDA Approval Process for Nuzyra

DateArticle
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
Apr  3, 2017Paratek Announces Positive Phase 3 Study of Omadacycline in Community-Acquired Bacterial Pneumonia
May 10, 2016Paratek Receives FDA Affirmation for Design of Proposed Omadacycline Oral-Only Skin Infection Phase 3 Study
Jun 23, 2015Paratek Doses First Patient in Phase 3 Clinical Trial of Omadacycline in Acute Bacterial Skin and Skin Structure Infections
Oct 27, 2008Paratek Reports Positive Phase 2 Clinical Data on its New Antibiotic PTK 0796 in Late Breaker Presentation at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy
Oct 14, 2008Paratek to Present Clinical Data in Late Breaker Presentation at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy

Further information

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

Hide