BLA 17067, held by Fresenius Kabi USA. Gonadotropin, Chorionic.
As of Nov 13, 2026, BLA 17067 (Chorionic Gonadotropin), held by Fresenius Kabi USA, was first approved by FDA on Mar 5, 1973, with 42 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 1981 | Supplement 42Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1980 | Supplement 38Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1980 | Supplement 37Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1980 | Supplement 35Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1980 | Supplement 33Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1980 | Supplement 32Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1980 | Supplement 30Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1980 | Supplement 29Efficacy (new indication or use) | Approved | None posted |
| Dec 18, 1979 | Supplement 39Efficacy (new indication or use) | Approved | None posted |
| Dec 18, 1979 | Supplement 34Efficacy (new indication or use) | Approved | None posted |
| Dec 18, 1979 | Supplement 31Efficacy (new indication or use) | Approved | None posted |
| Dec 18, 1979 | Supplement 28Efficacy (new indication or use) | Approved | None posted |
| Mar 9, 1978 | Supplement 25Efficacy (new indication or use) | Approved | None posted |
| Mar 9, 1978 | Supplement 24Efficacy (new indication or use) | Approved | None posted |
| Mar 9, 1978 | Supplement 23Efficacy (new indication or use) | Approved | None posted |
| Mar 9, 1978 | Supplement 17Efficacy (new indication or use) | Approved | None posted |
| Mar 5, 1973 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Chorionic Gonadotropin5,000 UNITS/VIAL · injectable;injection | Gonadotropin, Chorionic | Discontinued |
| Chorionic Gonadotropin10,000 UNITS/VIAL · injectable;injection | Gonadotropin, Chorionic | Rx |
| Chorionic Gonadotropin20,000 UNITS/VIAL · injectable;injection | Gonadotropin, Chorionic | Discontinued |
| Chorionic Gonadotropin15,000 UNITS/VIAL · injectable;injection | Gonadotropin, Chorionic | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 2, 2023 | Supplement 66Labeling · Standard review | Approved | |
| Sep 10, 2015 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Jan 29, 2014 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Feb 16, 2013 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Apr 15, 2011 | Supplement 57Labeling | Approved | |
| Nov 14, 2002 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Mar 6, 1997 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Feb 11, 1993 | Supplement 51Labeling | Approved | None posted |
| Aug 15, 1991 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1991 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Aug 5, 1987 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Jan 10, 1986 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| May 16, 1984 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Oct 20, 1982 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Feb 3, 1982 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jul 13, 1981 | Supplement 42Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1980 | Supplement 38Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1980 | Supplement 37Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1980 | Supplement 35Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1980 | Supplement 33Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1980 | Supplement 32Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1980 | Supplement 30Efficacy (new indication or use) | Approved | None posted |
| Aug 13, 1980 | Supplement 29Efficacy (new indication or use) | Approved | None posted |
| Jul 22, 1980 | Supplement 22Labeling | Approved | None posted |
| Jul 22, 1980 | Supplement 20Labeling | Approved | None posted |
| Jul 22, 1980 | Supplement 19Labeling | Approved | None posted |
| Jul 22, 1980 | Supplement 11Labeling | Approved | None posted |
| Jul 22, 1980 | Supplement 10Labeling | Approved | None posted |
| Jul 22, 1980 | Supplement 9Labeling | Approved | None posted |
| Jul 22, 1980 | Supplement 2Labeling | Approved | None posted |
| Dec 18, 1979 | Supplement 39Efficacy (new indication or use) | Approved | None posted |
| Dec 18, 1979 | Supplement 34Efficacy (new indication or use) | Approved | None posted |
| Dec 18, 1979 | Supplement 31Efficacy (new indication or use) | Approved | None posted |
| Dec 18, 1979 | Supplement 28Efficacy (new indication or use) | Approved | None posted |
| Dec 18, 1979 | Supplement 27Labeling | Approved | None posted |
| Dec 18, 1979 | Supplement 21Labeling | Approved | None posted |
| Dec 18, 1979 | Supplement 15Labeling | Approved | None posted |
| Dec 18, 1979 | Supplement 8Labeling | Approved | None posted |
| Mar 9, 1978 | Supplement 25Efficacy (new indication or use) | Approved | None posted |
| Mar 9, 1978 | Supplement 24Efficacy (new indication or use) | Approved | None posted |
| Mar 9, 1978 | Supplement 23Efficacy (new indication or use) | Approved | None posted |
| Mar 9, 1978 | Supplement 17Efficacy (new indication or use) | Approved | None posted |
| Mar 5, 1973 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
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
