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Published On: Thu, Jan 3rd, 2013

Paratek Pharmaceutical’s ‘omadacycline’ gets QIDP designation from the FDA

The Global Dispatch logoBoston, MA company, Paratek Pharmaceuticals, Inc announced today that their lead product candidate, omadacycline received the Food and Drug Administration’s (FDA)  Qualified Infectious Disease Product (QIDP) designation for both oral and IV formulations, according to a company press release Jan. 3.

The antibiotic candidate, formerly known as PTK 0796, is a new tetracycline-derived, broad-spectrum antibiotic being developed for use as a first-line monotherapy for serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections (ABSSSI),community-acquired bacterial pneumonia (CABP) and urinary tract infections (UTI),  where antibiotic resistance is an area of concern.

The QIDP designation provides Paratek access to certain incentives, including priority review associated with a New Drug Application (NDA) submission, eligibility for fast-track status for smaller population studies targeting certain resistant organisms, and a five-year extension of exclusivity under the Hatch-Waxman Act upon FDA approval of omadacycline, according to the release.

Paratek has completed clinical studies necessary to advance oral and IV formulations of omadacycline into Phase 3 development.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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  1. Paratek receives FDA QIDP designation for omadacycline to treat ABSSSI, CABP – News-Medical.net says:

    […] (formerly known as PTK 0796), as a Qualified Infectious Disease Product (QIDP) for …Paratek Pharmaceutical's 'omadacycline' gets QIDP designation from the FDAThe Global Dispatchall 11 news […]

  2. Paratek Pharmaceutical’s ‘omadacycline’ gets QIDP designation from the FDA – The Global Dispatch says:

    […] Paratek Pharmaceutical's 'omadacycline' gets QIDP designation from the FDAThe Global DispatchThe Global Dispatch logo Boston, MA company, Paratek Pharmaceuticals, Inc announced today that their lead product candidate, omadacycline received the Food and Drug Administration's (FDA) Qualified Infectious Disease Product (QIDP) designation for …Paratek Pharmaceuticals Announces FDA Grant of Qualified Infectious Disease …PharmaLive (press release) (subscription)all 10 news articles » […]

  3. Paratek Pharmaceutical’s ‘omadacyclin… – The Global Dispatch says:

    […] Paratek Pharmaceutical's 'omadacyclin…The Global DispatchThe Global Dispatch logo Boston, MA company, Paratek Pharmaceuticals, Inc announced today that their lead product candidate, omadacycline received the Food and Drug Administration's (FDA) Qualified Infectious Disease Product (QIDP) designation for …Paratek Pharmaceuticals Announces FDA Grant of Qualified Infectious Disease …PharmaLive (press release) (subscription)all 10 news articles » […]

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