Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 207947
Company: ACTELION

Summary Review

Products on NDA 207947

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
UPTRAVI	SELEXIPAG	0.2MG	TABLET;ORAL	Prescription	AB	Yes	No
UPTRAVI	SELEXIPAG	0.4MG	TABLET;ORAL	Prescription	AB	Yes	Yes
UPTRAVI	SELEXIPAG	0.6MG	TABLET;ORAL	Prescription	AB	Yes	No
UPTRAVI	SELEXIPAG	0.8MG	TABLET;ORAL	Prescription	AB	Yes	No
UPTRAVI	SELEXIPAG	1MG	TABLET;ORAL	Prescription	AB	Yes	No
UPTRAVI	SELEXIPAG	1.2MG	TABLET;ORAL	Prescription	AB	Yes	No
UPTRAVI	SELEXIPAG	1.4MG	TABLET;ORAL	Prescription	AB	Yes	No
UPTRAVI	SELEXIPAG	1.6MG	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207947

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/2015/207947s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207947Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207947Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207947Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
08/19/2021	SUPPL-10	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207947Orig1s010ltr.pdf
10/25/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207947Orig1s009ltr.pdf
01/30/2021	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207947Orig1s008ltr.pdf
09/04/2019	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207947s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207947Orig1s007ltr.pdf
12/20/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207947Orig1s005ltr.pdf
09/28/2017	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207947Orig1s003ltr.pdf
07/21/2017	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207947Orig1s001ltr.pdf

Labels for NDA 207947

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
10/25/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s009lbl.pdf
08/19/2021	SUPPL-10	Labeling-Patient Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s010lbl.pdf
08/19/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s010lbl.pdf
01/30/2021	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s008lbl.pdf
09/04/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207947s007lbl.pdf
12/20/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s005lbl.pdf
09/28/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s003lbl.pdf
07/21/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s001lbl.pdf
12/21/2015	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/2015/207947s000lbl.pdf

Therapeutic Equivalents for NDA 207947

UPTRAVI

TABLET;ORAL; 0.2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SELEXIPAG	SELEXIPAG	0.2MG	TABLET;ORAL	Prescription	No	AB	214414	ALEMBIC
UPTRAVI	SELEXIPAG	0.2MG	TABLET;ORAL	Prescription	Yes	AB	207947	ACTELION

TABLET;ORAL; 0.4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SELEXIPAG	SELEXIPAG	0.4MG	TABLET;ORAL	Prescription	No	AB	214414	ALEMBIC
UPTRAVI	SELEXIPAG	0.4MG	TABLET;ORAL	Prescription	Yes	AB	207947	ACTELION

TABLET;ORAL; 0.6MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SELEXIPAG	SELEXIPAG	0.6MG	TABLET;ORAL	Prescription	No	AB	214414	ALEMBIC
UPTRAVI	SELEXIPAG	0.6MG	TABLET;ORAL	Prescription	Yes	AB	207947	ACTELION

TABLET;ORAL; 0.8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SELEXIPAG	SELEXIPAG	0.8MG	TABLET;ORAL	Prescription	No	AB	214414	ALEMBIC
UPTRAVI	SELEXIPAG	0.8MG	TABLET;ORAL	Prescription	Yes	AB	207947	ACTELION

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
UPTRAVI	SELEXIPAG	1MG	TABLET;ORAL	Prescription	Yes	AB	207947	ACTELION

TABLET;ORAL; 1.2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
UPTRAVI	SELEXIPAG	1.2MG	TABLET;ORAL	Prescription	Yes	AB	207947	ACTELION

TABLET;ORAL; 1.4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SELEXIPAG	SELEXIPAG	1.4MG	TABLET;ORAL	Prescription	No	AB	214414	ALEMBIC
UPTRAVI	SELEXIPAG	1.4MG	TABLET;ORAL	Prescription	Yes	AB	207947	ACTELION

TABLET;ORAL; 1.6MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SELEXIPAG	SELEXIPAG	1.6MG	TABLET;ORAL	Prescription	No	AB	214414	ALEMBIC
UPTRAVI	SELEXIPAG	1.6MG	TABLET;ORAL	Prescription	Yes	AB	207947	ACTELION