Tobi Podhaler

Manages Pseudomonas aeruginosa. NDA 201688, held by Viatris. Tobramycin.

As of Nov 13, 2026, NDA 201688 (Tobi Podhaler), held by Viatris, was first approved by FDA on Mar 22, 2013, with 11 approved supplements and 0 published complete response letters.

First approved: Mar 22, 2013
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TOBI Podhaler is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) <25% or >80% predicted, or patients colonized with Burkholderia cepacia.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Mar 22, 2013	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tobi Podhaler28MG · powder;inhalation	Tobramycin	RxReference drug

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 10, 2023	Supplement 19Labeling · Standard review	Approved	Letter Label
Jul 13, 2020	Supplement 10Labeling · Standard review	Approved	Letter Label
Jan 27, 2017	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 16, 2016	Supplement 8Labeling · Standard review	Approved	Letter Label
Jan 6, 2016	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 2, 2015	Supplement 6Labeling · Standard review	Approved	Label Letter
Sep 11, 2015	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 19, 2014	Supplement 4Labeling · Standard review	Approved	Letter Label
Sep 30, 2014	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 25, 2014	Supplement 2Labeling · Standard review	Approved	Letter Label
Jan 7, 2014	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 22, 2013	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: TOBI PODHALERJul 13, 2026

Identifiers

Application: NDA 201688
Drugs@FDA: Overview at FDA
Company: Viatris

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