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
|Oct 2, 2018|| FDA Approves Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and Acute Skin and Skin Structure Infections|
|Aug 8, 2018||FDA Advisory Committee Recommends Approval of Paratek’s Omadacycline|
|Jun 11, 2018||Paratek Presents New Analysis from Combined Phase 3 Skin Infection Studies Highlighting Efficacy of Omadacycline in Treating Drug Resistant S. aureus|
|Apr 4, 2018||Paratek’s New Drug Applications for Oral and Intravenous Omadacycline Accepted for Priority Review by FDA|
|Feb 5, 2018||Paratek Completes Submission of New Drug Applications to U.S. FDA for Oral and Intravenous Omadacycline for Pneumonia and Skin Infections|
|Jul 17, 2017||Paratek 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, 2017||Paratek Announces Positive Phase 3 Study of Omadacycline in Community-Acquired Bacterial Pneumonia|
|May 10, 2016||Paratek Receives FDA Affirmation for Design of Proposed Omadacycline Oral-Only Skin Infection Phase 3 Study|
|Jun 23, 2015||Paratek Doses First Patient in Phase 3 Clinical Trial of Omadacycline in Acute Bacterial Skin and Skin Structure Infections|
|Oct 27, 2008||Paratek 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, 2008||Paratek to Present Clinical Data in Late Breaker Presentation at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy|
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