Dostinex

Treats hyperprolactinemic disorders. NDA 20664, held by Pfizer. Cabergoline.

As of Nov 13, 2026, NDA 20664 (Dostinex), held by Pfizer, was first approved by FDA on Dec 23, 1996, with 14 approved supplements and 0 published complete response letters.

First approved: Dec 23, 1996
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CABERGOLINE is an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. Limitations of Use Avoid use of CABERGOLINE for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below


Aug 11, 2011	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 23, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dostinex0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Cabergoline	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Apr 21, 2025	Supplement 16Labeling	Approved	Letter Label
Dec 13, 2019	Supplement 17Labeling · Standard review	Approved	Letter Label
Aug 29, 2014	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 26, 2014	Supplement 13Labeling · Standard review	Approved	Letter Label
May 30, 2014	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 11, 2011	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 18, 2011	Supplement 11Labeling	Approved	Letter Label
Dec 19, 2007	Supplement 10Labeling · Standard review	Approved	Letter Label
Feb 9, 2007	Supplement 7Manufacturing · Standard review	Approved	Letter Label
Dec 12, 2006	Supplement 8Labeling · Standard review	Approved	Letter Label
Apr 17, 2000	Supplement 4Labeling · Standard review	Approved	None posted
May 15, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 15, 1997	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 15, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 23, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20664
Drugs@FDA: Overview at FDA
Company: Pfizer

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