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FDA Approves Nuzyra for Acute Skin Infections

Paratek Pharmaceuticals, Inc. news release; 2018 Oct 2

Paratek Pharmaceuticals, Inc. has announced that the US Food and Drug Administration (FDA) has approved Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). Paratek Pharmaceuticals is headquartered in Boston, MA.

Indications: Nuzyra, a modernized tetracycline, is a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug resistant strains. Nuzyra will be available in the first quarter 2019.

Dosage/administration: For injection: 100 mg of omadacycline (equivalent to 131 mg

omadacycline tosylate) as a lyophilized powder in a single dose vial for reconstitution and further dilution before intravenous infusion. For tablets: 150 mg omadacycline (equivalent to 196 mg omadacycline tosylate). More detailed dosage information can be found at www.nuzyra.com/PI.pdf.

Adverse reactions: The most common adverse reactions (incidence ≥2%) are nausea,

vomiting, infusion site reactions, alanine aminotransferase increase, aspartate aminotransferase increase, gamma-glutamyl transferase increase, hypertension, headache, diarrhea, insomnia, and constipation.

Citation:

Paratek announces FDA approval of Nuzyra (omadacycline). [news release] Boston, MA: Paratek Pharmaceuticals, Inc. October 2, 2018. https://globenewswire.com/news-release/2018/10/02/1600459/0/en/Paratek-Announces-FDA-Approval-of-NUZYRA-Omadacycline.html. Accessed October 18, 2018.