Pylera

Treats Helicobacter pylori infection and duodenal ulcer disease (active or history of…. NDA 50786, held by Labs Juvise. Bismuth Subcitrate Potassium; Metronidazole; Tetracycline Hydrochloride.

As of Nov 13, 2026, NDA 50786 (Pylera), held by Labs Juvise, was first approved by FDA on Sep 28, 2006, with 19 approved supplements and 0 published complete response letters.

First approved: Sep 28, 2006
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PYLERA is a combination of metronidazole, a nitroimidazole antimicrobial, tetracycline,- a tetracycline class antimicrobial and bismuth subcitrate potassium, indicated for use, in combination with omeprazole, for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA and other antibacterial drugs, PYLERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Sep 28, 2006	Original applicationNew molecular entity, new combination · Standard review	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pylera140MG;125MG;125MG · capsule;oral	Bismuth Subcitrate Potassium; Metronidazole; Tetracycline Hydrochloride	RxReference drug

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 21, 2025	Supplement 30Labeling · Standard review	Approved	Letter Label
Mar 31, 2025	Supplement 29Labeling · Standard review	Approved	Letter Label
Sep 19, 2024	Supplement 27Labeling · Standard review	Approved	Label Letter
Jul 8, 2024	Supplement 26Labeling · Standard review	Approved	Letter Label
Dec 15, 2021	Supplement 25Labeling · Standard review	Approved	Letter Label
Mar 5, 2021	Supplement 23Labeling · Standard review	Approved	Letter Label
Oct 5, 2018	Supplement 19Labeling · Standard review	Approved	Letter Label
Jan 25, 2018	Supplement 17Labeling · Standard review	Approved	Label Letter
May 30, 2017	Supplement 16Labeling · Standard review	Approved	Letter Label
Jan 25, 2017	Supplement 12Labeling · Standard review	Approved	Letter Label
Jan 19, 2017	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 26, 2016	Supplement 14Manufacturing · Standard review	Approved	None posted
May 28, 2014	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 5, 2014	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 14, 2013	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 5, 2013	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 23, 2013	Supplement 7Labeling · Standard review	Approved	Letter Label
Jan 19, 2011	Supplement 3Labeling · Standard review	Approved	Letter
May 24, 2007	Supplement 1Manufacturing	Approved	Label Letter
Sep 28, 2006	Original applicationNew molecular entity, new combination · Standard review	Approved	Review Letter

Identifiers

Application: NDA 50786
Drugs@FDA: Overview at FDA
Company: Labs Juvise

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