Ddavp

Manages central diabetes insipidus. NDA 19955, held by Ferring Pharms Inc. Desmopressin Acetate.

As of Nov 13, 2026, NDA 19955 (Ddavp), held by Ferring Pharms Inc, was first approved by FDA on Sep 6, 1995, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 6, 1995
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Central Diabetes Insipidus: Desmopressin Acetate Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Mar 25, 1998	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 6, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Ddavp0.1MG · tablet;oral	Desmopressin Acetate	RxReference drug
Ddavp0.2MG · tablet;oral	Desmopressin Acetate	RxReference drug

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 28, 2014	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 26, 2007	Supplement 13Labeling · Standard review	Approved	Label Letter
Nov 10, 2005	Supplement 10Labeling · Standard review	Approved	Letter Label
Nov 12, 2003	Supplement 5Labeling · Standard review	Approved	Letter
Oct 31, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 24, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 25, 1998	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 6, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19955
Drugs@FDA: Overview at FDA
Company: Ferring 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