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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011366
Company: XERIS

Products on NDA 011366

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DARANIDE	DICHLORPHENAMIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
KEVEYIS	DICHLORPHENAMIDE	50MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011366

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/22/1958	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2019	SUPPL-33	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)	Label and Letter for KEVEYIS	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011366s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/011366Orig1s033ltr.pdf
08/07/2015	SUPPL-30	Efficacy-New Indication	Label (PDF) Letter (PDF)	Label and Letter for KEVEYIS	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011366s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011366Orig1s030ltr.pdf
12/19/2013	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
03/16/2012	SUPPL-28	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/011366s028ltr.pdf
10/24/1994	SUPPL-27	Labeling		Label is not available on this site.
06/13/1995	SUPPL-26	Manufacturing (CMC)-Control		Label is not available on this site.
06/02/1989	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
02/12/1991	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
09/06/1985	SUPPL-23	Labeling		Label is not available on this site.
09/06/1985	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
08/06/1984	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
02/26/1982	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
11/05/1986	SUPPL-18	Labeling		Label is not available on this site.
12/18/1979	SUPPL-17	Labeling		Label is not available on this site.
12/20/1979	SUPPL-16	Labeling		Label is not available on this site.
07/28/1978	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 011366

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2019	SUPPL-33	Efficacy-Labeling Change With Clinical Data	Label (PDF)	Label and Letter for KEVEYIS	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011366s033lbl.pdf
08/07/2015	SUPPL-30	Efficacy-New Indication	Label (PDF)	Label and Letter for KEVEYIS	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011366s030lbl.pdf

Therapeutic Equivalents for NDA 011366

DARANIDE

There are no Therapeutic Equivalents.

KEVEYIS

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KEVEYIS	DICHLORPHENAMIDE	50MG	TABLET;ORAL	Prescription	Yes	AB	011366	XERIS
ORMALVI	DICHLORPHENAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	215924	TORRENT

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