Pregnyl

BLA 17692, held by Organon USA LLC. Gonadotropin, Chorionic.

As of Nov 13, 2026, BLA 17692 (Pregnyl), held by Organon USA LLC, was first approved by FDA on Oct 20, 1976, with 23 approved supplements and 0 published complete response letters.

First approved: Oct 20, 1976
Review: Standard
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR “NORMAL” DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. Prepubertal cryptorchidism not due to anatomical obstruction. In general, hCG is thought to induce testicular descent in situations when descent would have occurred at puberty. hCG thus may help predict whether or not orchiopexy will be needed in the future.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Oct 20, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pregnyl10,000 UNITS/VIAL · injectable;injection	Gonadotropin, Chorionic	Rx

All 24 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 2, 2023	Supplement 43Labeling · Standard review	Approved	Label Letter
Mar 2, 2023	Supplement 36Labeling · Standard review	Approved	Label Letter
Mar 2, 2023	Supplement 28Labeling · Standard review	Approved	Label Letter
Oct 2, 2015	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 12, 2015	Supplement 25Manufacturing · Standard review	Approved	None posted
Feb 28, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 26, 2013	Supplement 23Manufacturing · Standard review	Approved	None posted
Apr 15, 2011	Supplement 21Labeling	Approved	Letter Label
Dec 3, 2007	Supplement 20Labeling · Standard review	Approved	Letter
Feb 7, 2007	Supplement 18Labeling · Standard review	Approved	Letter Label
Nov 23, 1999	Supplement 12Labeling · Standard review	Approved	None posted
Apr 2, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 21, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 30, 1992	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 2, 1991	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 3, 1988	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 19, 1988	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 17, 1987	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 24, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 9, 1984	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 5, 1982	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 3, 1981	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 20, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: BLA 17692
Drugs@FDA: Overview at FDA
Company: Organon USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters