FDA Approved Sexual & Reproductive Health

Urofollitropin

also known as: Bravelle, Fertinex, Metrodin HP, uFSH, highly purified urinary FSH

Ferring's Bravelle (and earlier Fertinex) — highly purified urinary-derived FSH used for ovulation induction and IVF controlled ovarian stimulation. FDA-approved 2002; branded Bravelle was withdrawn from the US market in 2015 due to manufacturing/potency concerns but the molecule class remains available via urinary-derived menotropin combination products.

Highly purified FSH extracted from the urine of postmenopausal women and further purified by immunoaffinity chromatography to remove LH, TSH, and other urinary glycoproteins. Historically the dominant FSH source for ovulation induction and IVF before recombinant follitropin alfa/beta became available. FDA-approved as Fertinex (1996) and then Bravelle (Ferring, 2002). Branded Bravelle in the United States was voluntarily withdrawn in October 2015 after Ferring identified a manufacturing-related potency variance; the urinary-FSH class remains represented in current practice primarily through urinary-derived menotropin combination products (Menopur, Repronex).

Mechanism of action

FSHR agonism identical to endogenous and recombinant FSH. Drives follicular recruitment and maturation in women; potency was historically standardized by the Steelman-Pohley rat ovarian-weight bioassay and later by in vitro cell assays.

Primary uses

  • Ovulation induction (historical/ex-US)
  • IVF controlled ovarian stimulation (historical/ex-US)

Typical dosing

75–225 IU/day daily (subcutaneous or intramuscular)

Ovulation induction: 150 IU SC/IM daily starting dose, titrated. IVF COH: 150–225 IU daily. Dosing practical equivalent of recombinant FSH.

Regulatory status

FDA-approved as Fertinex (Serono, 1996) and later as Bravelle (Ferring, 2002), both highly purified urinary FSH (uFSH-HP). Indications: ovulation induction in anovulatory infertility; development of multiple follicles during controlled ovarian stimulation for assisted reproduction. The branded Bravelle product was voluntarily withdrawn from the US market in October 2015 by Ferring due to identified manufacturing variance affecting potency assay results; the underlying molecule class (urinary FSH) remains in use through the menotropin combination product Menopur.

References

  1. [fda-pi] Bravelle (urofollitropin for injection, purified) Prescribing Information. Ferring Pharmaceuticals (historical; US market withdrawal October 2015).
  2. [other] Ferring Pharmaceuticals. "Voluntary Nationwide Recall of Bravelle (urofollitropin for injection, purified) in the United States." October 2015.

Related peptides

Follitropin alfa

EMD Serono's Gonal-f — the first recombinant human FSH approved by the FDA (1997). Used for ovulation induction, IVF controlled ovarian stimulation, and male hypogonadotropic hypogonadism fertility induction.

Follitropin beta

Organon/Merck's Follistim AQ (Puregon internationally) — a recombinant human FSH produced independently of follitropin alfa but clinically equivalent; FDA-approved 1997 for ovulation induction and IVF controlled ovarian stimulation.

Follitropin delta

Ferring's Rekovelle — a recombinant human FSH produced in a human cell line (PER.C6), dosed via a personalized algorithm based on serum AMH and body weight. Approved in the EU, UK, Canada, Australia, Japan, and China, but received an FDA Complete Response Letter in February 2026 over manufacturing issues; not currently approved in the United States.

Menotropin

Ferring's Menopur (and earlier Repronex, Humegon) — a urinary-derived FSH/LH combination used for ovulation induction and IVF controlled ovarian stimulation, particularly when LH supplementation is clinically desired.

HCG

An FDA-approved fertility and hypogonadism medication commonly discussed in peptide and TRT communities for post-cycle recovery and testicular preservation during testosterone therapy.
Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.