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# Committee Backs Paratek’s Omadacycline
- URL: https://www.fdaweb.com/committee-backs-parateks-omadacycline/
- Published: 2018-08-09T12:00:00.000Z
- Updated: 2026-09-15T00:24:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142080

The FDA Antimicrobial Drug Advisory Committee has voted to recommend to the agency that Paratek Pharmaceuticals’ intravenous and oral omadacycline is safe and effective for treating acute bacterial skin and skin structure infections and treating community-acquired bacterial pneumonia. Omadacycline is described as a modernized tetracycline being developed as a once-daily IV and oral broad spectrum antibiotic for the treatment of serious community-acquired infections.

Omadacycline has been granted qualified infectious disease product designation by FDA and fast track status for several target indications. The NDAs also are being given priority review.

The PDUFA action date for the company’s two omadacycline NDAs is in early Octoberp,a ratek says.