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.