R-Gene 10

NDA 16931, held by Pharmacia And Upjohn. Arginine Hydrochloride.

As of Nov 14, 2026, NDA 16931 (R-Gene 10), held by Pharmacia And Upjohn, was first approved by FDA on Feb 28, 1973, with 16 approved supplements and 0 published complete response letters.

First approved: Feb 28, 1973
Review: Priority
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE R-Gene 10 is indicated as an intravenous stimulant to the pituitary for the release of human growth hormone in patients where the measurement of pituitary reserve for HGH can be of diagnostic usefulness. It can be used as a diagnostic aid in such conditions as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism and problems of growth and stature. If the insulin hypoglycemia test has indicated a deficiency of pituitary reserve for HGH, a test with R-Gene 10 is advisable to confirm the negative response. This can be done after a waiting period of one day.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Feb 28, 1973	Original applicationNew formulation or manufacturer · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
R-Gene 1010GM/100ML · injectable;injection	Arginine Hydrochloride	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Jan 17, 2010	Supplement 31Labeling · Standard review	Approved	Letter Label
Aug 13, 2003	Supplement 28Labeling · Standard review	Approved	Label Letter
Apr 11, 2000	Supplement 27Manufacturing · Priority review	Approved	None posted
Mar 15, 1995	Supplement 26Labeling · Standard review	Approved	None posted
Mar 17, 1993	Supplement 25Manufacturing · Priority review	Approved	None posted
Oct 9, 1991	Supplement 24Manufacturing · Priority review	Approved	None posted
Feb 28, 1990	Supplement 23Labeling	Approved	None posted
Oct 24, 1989	Supplement 22Manufacturing · Priority review	Approved	None posted
Mar 5, 1986	Supplement 21Labeling	Approved	None posted
Jul 29, 1985	Supplement 20Labeling	Approved	None posted
Feb 19, 1985	Supplement 18Labeling	Approved	None posted
May 9, 1984	Supplement 19Manufacturing · Priority review	Approved	None posted
Jan 11, 1982	Supplement 17Manufacturing · Priority review	Approved	None posted
Jun 30, 1980	Supplement 14Labeling	Approved	None posted
Oct 1, 1975	Supplement 6Manufacturing · Priority review	Approved	None posted
Aug 25, 1975	Supplement 5Manufacturing · Priority review	Approved	None posted
Feb 28, 1973	Original applicationNew formulation or manufacturer · Priority review	Approved	None posted

Identifiers

Application: NDA 16931
Drugs@FDA: Overview at FDA
Company: Pharmacia & Upjohn

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