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To Be Discontinued Tablet Cardiovascular

Bosentan Tablet

Brand: TRACLEER

This drug is currently listed as to be discontinued by the FDA. Affected manufacturer: Actelion Pharmaceuticals.

Active FDA Drug Shortage

Contact your pharmacist if you are affected. They can check availability from other manufacturers or suggest alternatives.

Shortage Details

Generic Name
Bosentan Tablet
Manufacturer
Actelion Pharmaceuticals
Dosage Form
Tablet
Presentation
Tracleer, Tablet, 62.5 mg (NDC 66215-101-03)
Package NDC
66215-101-03

Status & Timeline

Status
To Be Discontinued
First Reported
Jun 9, 2025
Last Updated
Jun 9, 2025
Therapeutic Category
Cardiovascular

Nearby — Other Bosentan Shortage Records

Frequently Asked Questions

Why is Bosentan in shortage?
Drug shortages can result from manufacturing problems, quality issues, raw material shortages, or increased demand. The FDA works with manufacturers to resolve shortages as quickly as possible.
What can I do if my medication is in shortage?
Contact your pharmacist — they can check availability across suppliers or suggest an equivalent from a different manufacturer. Your prescriber may also recommend a therapeutic substitute from the same drug class.
How often is this data updated?
Shortage data comes from the FDA Drug Shortages Database via openFDA. The database is updated regularly as manufacturers report changes to the FDA.

What This Bosentan Shortage Record Means

The FDA Drug Shortages database lists this record for Bosentan Tablet (brand: TRACLEER) from Actelion Pharmaceuticals with a current status of To Be Discontinued. The affected dosage form is Tablet, presented as Tracleer, Tablet, 62.5 mg (NDC 66215-101-03). Shortages are tracked at the manufacturer and presentation level — other manufacturers or formulations of the same generic may remain available, which is why pharmacists often can source a working substitute even when one record is flagged.

This shortage was first reported on Jun 9, 2025 and was last updated Jun 9, 2025. FDA-supplied reason codes are not recorded for this entry; common drivers include manufacturing quality issues, raw-material constraints, demand surges, and voluntary business decisions to discontinue a presentation. There is 1 other current record in this database covering the same generic, which gives a fuller picture of how disruption is playing out across manufacturers and dosage forms.

A shortage listing is a supply-side signal, not a patient-level instruction. Access can vary dramatically by pharmacy, region, hospital system, and insurance formulary — local pharmacists have real-time visibility that a national database cannot provide. Therapeutic substitutes often exist in the same class, but switching decisions belong with your prescriber, who weighs efficacy, dosing conversion, interaction profile, and personal history. This page summarizes public FDA data for educational reference only and is not medical advice. If your medication is affected, contact your pharmacist and prescriber to plan an appropriate response.

Disclaimer: This information comes from the FDA Drug Shortages Database and is for educational purposes only. It is not medical advice. Do not stop or change any medication without consulting your healthcare provider or pharmacist. Shortage status can change rapidly — always verify current availability with your pharmacist.