Nuzyra

NDA 209816, held by Paratek Pharms. Omadacycline Tosylate.

As of Nov 13, 2026, NDA 209816 (Nuzyra), held by Paratek Pharms, was first approved by FDA on Oct 2, 2018, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 2, 2018
Review: Priority
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms: Community-acquired bacterial pneumonia (CABP) Acute bacterial skin and skin structure infections (ABSSSI) To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Community-Acquired Bacterial Pneumonia

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


May 13, 2026	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 27, 2021	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 2, 2018	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
NuzyraEQ 150MG BASE · tablet;oral	Omadacycline Tosylate	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


May 13, 2026	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 31, 2025	Supplement 17Labeling · Standard review	Approved	Letter Label
May 27, 2021	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 11, 2021	Supplement 12Labeling · Standard review	Approved	Letter
Oct 20, 2020	Supplement 9Labeling · Standard review	Approved	Label Letter
Sep 2, 2020	Supplement 8Labeling · Standard review	Approved	Label Letter
Jun 13, 2019	Supplement 4Labeling · Standard review	Approved	Letter Label
Jun 13, 2019	Supplement 3Labeling · Standard review	Approved	Letter Label
Jun 13, 2019	Supplement 2Labeling · Standard review	Approved	Letter Label
Oct 2, 2018	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 209816
Drugs@FDA: Overview at FDA
Company: Paratek Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters