Samsca

As of Nov 14, 2026, NDA 22275 (Samsca), held by Otsuka, was first approved by FDA on May 19, 2009, with 11 approved supplements and 0 published complete response letters.

First approved: May 19, 2009
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SAMSCA is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
May 19, 2009	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Products

3 strengths and forms


Samsca15MG · tablet;oral	Tolvaptan	RxReference drug
Samsca30MG · tablet;oral	Tolvaptan	RxReference drug
Samsca60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Tolvaptan	DiscontinuedReference drug

All 12 submissions, including labeling and manufacturing supplements


Apr 22, 2021	Supplement 17Labeling · Standard review	Approved	Label Medication Guide
Apr 23, 2018	Supplement 16Labeling · Standard review	Approved	Letter Label Medication Guide
Jun 1, 2017	Supplement 15Labeling · Standard review	Approved	Letter Label
Feb 28, 2014	Supplement 14Labeling · Standard review	Approved	Letter Label
Sep 27, 2013	Supplement 10Manufacturing · Standard review	Approved	None posted
May 2, 2013	Supplement 11Labeling · Standard review	Approved	Label Letter
Apr 9, 2013	Supplement 9Labeling · Standard review	Approved	Letter Label
Nov 16, 2012	Supplement 7Labeling	Approved	Label Letter
Sep 14, 2012	Supplement 8REMS	Approved	Letter
Feb 1, 2012	Supplement 5Labeling	Approved	Letter Label
Sep 23, 2011	Supplement 3REMS	Approved	Letter
May 19, 2009	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22275
Drugs@FDA: Overview at FDA
Company: Otsuka Pharmaceutical

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