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U.S. FDA approves Nuzyra (Omacycline) for oral administration only

 Last Update: 2021-06-22
 Source: Internet
 Author: User

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Zai Lab partner Paratek Pharmaceuticals recently announced that the U.
S.
Food and Drug Administration (FDA) has approved a supplementary new drug application (sNDA) for Nuzyra (omadacycline, omacycline tosylate, or "omacycline" for short).
): The oral-only dosing regimen of Nuzyra is used to treat adult patients with community-acquired bacterial pneumonia (CABP)
.

Previously, Nuzyra's administration regimen for CABP was an intravenous-oral regimen

Recently, the FDA also approved Nuzyra's oral dosing regimen for the treatment of acute bacterial skin and skin tissue infections (ABSSSI) in adult patients
.

Previously, Nuzyra's dosing regimen for the treatment of ABSSI was also an intravenous-oral regimen

Nuzyra was approved by the FDA in October 2018.
The drug is a modern tetracycline antibiotic that is administered orally or intravenously once a day for the treatment of CABP and ABSSSI
.

The newly approved oral-only dosing regimen will enable doctors to treat patients in outpatient or primary care facilities, reducing or eliminating the risks and costs during hospitalization and hospitalization

Omadacycline is a new type of 9-aminomethylcycline drug.

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