For primary and secondary hypogonadotropic hypogonadism. Sold as Gonal-F, Follistim, Follistim Aq, Gonal-F Rff Redi-Ject, Gonal-F Rff. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 6 applications for Follitropin Alfa/Beta (sold as Gonal-F, Follistim, Follistim Aq and others), first approved Sep 29, 1997, with 4 new uses approved and 0 published complete response letters.
| Sep 29, 1997 | Gonal-FBLA 20378 · New dosage form | Emd Serono | 47 | Marketed |
| Sep 29, 1997 | FollistimBLA 20582 · New dosage form | Organon USA Inc | 7 | Discontinued |
| Mar 23, 2004 | Follistim AqBLA 21211 · New dosage form | Organon USA LLC | 11 | Marketed |
| Mar 25, 2004 | Gonal-F, Gonal-F RffBLA 21765 · New dosage form | Emd Serono | 21 | Marketed |
| May 25, 2004 | Gonal-F Rff Redi-JectBLA 21684 · New dosage form | Emd Serono | 14 | Marketed |
| Aug 26, 2005 | Follistim AqBLA 21273 · New dosage form | Organon USA Inc | 5 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
