Paratek Pharmaceuticals Stock Trading Halted Today; FDA Advisory Committee to Review Omadacycline New Drug Applications

Pharmaceutical Investing

Paratek Pharmaceuticals (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today announced that NASDAQ has halted trading of the company’s common stock. As quoted in the press release: The U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee is meeting today to review Paratek’s omadacycline, …

As quoted in the press release:

The U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee is meeting today to review Paratek’s omadacycline, an investigational once-daily oral and intravenous broad spectrum antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
The Advisory Committee meeting is scheduled from 8:30 a.m. to 1 p.m. ET. The briefing materials can be found on the FDA website. The Prescription Drug User Fee Act (PDUFA) date for completion of the review of the company’s New Drug Application for omadacycline is in early October 2018.
Advisory committees provide independent advice and recommendations to the Food and Drug Administration (FDA) on scientific and technical matters related to the development and evaluation of products regulated by the Agency.

Click here to read the full press release.

nasdaq:prtk paratek pharmaceuticals Pharmaceutical Investing