Daranide, Keveyis

Treats primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis…. NDA 11366, held by Xeris. Dichlorphenamide.

As of Nov 14, 2026, NDA 11366 (Daranide, Keveyis), held by Xeris, was first approved by FDA on Jul 22, 1958, with 16 approved supplements and 0 published complete response letters.

First approved: Jul 22, 1958
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

KEVEYIS is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Nov 22, 2019	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 7, 2015	Supplement 30Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 22, 1958	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Daranide50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Dichlorphenamide	DiscontinuedReference drug
Keveyis50MG · tablet;oral	Dichlorphenamide	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Nov 22, 2019	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 7, 2015	Supplement 30Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 19, 2013	Supplement 29Manufacturing · Standard review	Approved	None posted
Mar 16, 2012	Supplement 28Manufacturing · Standard review	Approved	Letter
Jun 13, 1995	Supplement 26Manufacturing · Standard review	Approved	None posted
Oct 24, 1994	Supplement 27Labeling · Standard review	Approved	None posted
Feb 12, 1991	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 2, 1989	Supplement 25Manufacturing · Standard review	Approved	None posted
Nov 5, 1986	Supplement 18Labeling	Approved	None posted
Sep 6, 1985	Supplement 23Labeling	Approved	None posted
Sep 6, 1985	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 6, 1984	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 26, 1982	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 20, 1979	Supplement 16Labeling	Approved	None posted
Dec 18, 1979	Supplement 17Labeling	Approved	None posted
Jul 28, 1978	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 22, 1958	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 11366
Drugs@FDA: Overview at FDA
Company: Xeris Pharmaceuticals

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