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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209279
Company: ACTELION

Medication Guide

REMS

Products on NDA 209279

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRACLEER	BOSENTAN	32MG	TABLET, FOR SUSPENSION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209279

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/05/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209279s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209279Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2025	SUPPL-15	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021290Orig1s048, 209279Orig1s015Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021290Orig1s048,209279Orig1s015ltr.pdf
07/30/2025	SUPPL-14	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021290Orig1s047;209279Orig1s014ltr.pdf
02/21/2025	SUPPL-12	REMS - MODIFIED - D-N-A		Label is not available on this site.
09/17/2024	SUPPL-11	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021290Orig1s045, 209279Orig1s011ltr.pdf
02/08/2024	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021290s044,209279s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021290Orig1s044, 209279Orig1s010ltr.pdf
04/29/2022	SUPPL-9	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021290Orig1s043, 209279Orig1s009ltr.pdf
07/29/2021	SUPPL-8	Manufacturing (CMC)-Manufacturing Process	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209279Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209279Orig1s008ltr.pdf
05/16/2019	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s039,209279s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021290Orig1s039, 209279Orig1s005ltr.pdf
04/26/2019	SUPPL-4	REMS - MODIFIED - BIFURCATED	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s032,209279s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021290Orig1s032; 209279Orig1s004ltr.pdf
10/25/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021290s037,209279s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209279Orig1s002,021290Orig1s037ltr.pdf
10/20/2017	SUPPL-1	REMS - MODIFIED - D-N-A	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021290Orig1s035,209279Orig1s001Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209279Orig1s000TOC.html

Labels for NDA 209279

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2025	SUPPL-15	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021290Orig1s048, 209279Orig1s015Lbl.pdf
02/08/2024	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021290s044,209279s010lbl.pdf
07/29/2021	SUPPL-8	Manufacturing (CMC)-Manufacturing Process	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209279Orig1s008lbl.pdf
05/16/2019	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s039,209279s005lbl.pdf
05/16/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s039,209279s005lbl.pdf
04/26/2019	SUPPL-4	REMS - MODIFIED - BIFURCATED	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s032,209279s004lbl.pdf
10/25/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021290s037,209279s002lbl.pdf
09/05/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209279s000lbl.pdf

Therapeutic Equivalents for NDA 209279

TRACLEER

TABLET, FOR SUSPENSION;ORAL; 32MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BOSENTAN	BOSENTAN	32MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	213154	NATCO PHARMA LTD
TRACLEER	BOSENTAN	32MG	TABLET, FOR SUSPENSION;ORAL	Prescription	Yes	AB	209279	ACTELION

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