Veltassa

Treats hyperkalemia. NDA 205739, held by Vifor Pharma. Patiromer Sorbitex Calcium.

As of Nov 14, 2026, NDA 205739 (Veltassa), held by Vifor Pharma, was first approved by FDA on Oct 21, 2015, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 21, 2015
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Veltassa is indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older. Limitation of Use: Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Oct 2, 2023	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Label
May 2, 2018	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 21, 2015	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

4 strengths and forms


VeltassaEQ 8.4GM BASE/PACKET · powder;oral	Patiromer Sorbitex Calcium	RxReference drug
VeltassaEQ 16.8GM BASE/PACKET · powder;oral	Patiromer Sorbitex Calcium	RxReference drug
VeltassaEQ 25.2GM BASE/PACKET · powder;oral	Patiromer Sorbitex Calcium	DiscontinuedReference drug
VeltassaEQ 1GM BASE/PACKET · powder;oral	Patiromer Sorbitex Calcium	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Oct 2, 2023	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Label
Mar 27, 2023	Supplement 37Labeling · Standard review	Approved	Letter Label
Dec 22, 2021	Supplement 35Labeling · Standard review	Approved	Letter Label
May 14, 2021	Supplement 31Labeling · Standard review	Approved	Label Letter
May 2, 2018	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 1, 2016	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 25, 2016	Supplement 9Labeling · Standard review	Approved	Label Letter
Jun 16, 2016	Supplement 5Manufacturing · Standard review	Approved	None posted
May 20, 2016	Supplement 1Labeling · Standard review	Approved	Letter Label
May 10, 2016	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 21, 2015	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 205739
Drugs@FDA: Overview at FDA
Company: Vifor Pharma

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