Bosentan

Treats pulmonary arterial hypertension (PAH) (WHO Group 1). ANDA 207760, held by Zydus Pharms. Bosentan.

As of Nov 14, 2026, ANDA 207760 (Bosentan), held by Zydus Pharms, was first approved by FDA on Apr 26, 2019, with 10 approved supplements and 0 published complete response letters.

First approved: Apr 26, 2019
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%). in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Apr 26, 2019	Original application	Approved	REMS

Products

2 strengths and forms


Bosentan62.5MG · tablet;oral	Bosentan	Rx
Bosentan125MG · tablet;oral	Bosentan	Rx

All 11 submissions, including labeling and manufacturing supplements


Oct 27, 2026	Supplement 17REMS	Approved	None posted
Apr 14, 2026	Supplement 14Labeling · Standard review	Approved	None posted
Apr 14, 2026	Supplement 15Labeling · Standard review	Approved	None posted
Mar 3, 2026	Supplement 16REMS	Approved	None posted
Nov 5, 2025	Supplement 13REMS	Approved	None posted
Feb 21, 2025	Supplement 11REMS	Approved	None posted
Sep 17, 2024	Supplement 10REMS	Approved	None posted
May 30, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Apr 29, 2022	Supplement 6REMS	Approved	None posted
Nov 1, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Apr 26, 2019	Original application	Approved	REMS

Identifiers

Application: ANDA 207760
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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