🏅 FDA Orphan Designation

Gonal-F

Follitropin alfa, recombinant

Manufacturer: EMD Serono, Inc.

Indicated for:

Endocrinopathy with congenital hypogonadotropic hypogonadism as a major featureOrphanGenetic infertilityNON RARE IN EUROPE: Aldosterone-producing adenomaKallmann syndrome

FDA-Approved Indications (4)

Endocrinopathy with congenital hypogonadotropic hypogonadism as a major featureOrphan Designation

For the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Genetic infertility

Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure.

Population: women

NON RARE IN EUROPE: Aldosterone-producing adenoma

Development of multiple follicles in ovulatory infertile women as part of an assisted reproductive technology (ART) cycle.

Population: women

Kallmann syndrome

Induction of spermatogenesis in infertile men with primary and secondary hypogonadotropic hypogonadism for whom the cause of infertility is not due to primary testicular failure.

Population: men

Indications & Usage

1 INDICATIONS AND USAGE GONAL-f is indicated for: GONAL-f is a gonadotropin indicated for: Women: Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure. ( 1.1 ) Development of multiple follicles in ovulatory infertile women as part of Assisted Reproductive Technology (ART) cycles. ( 1.2 ) Men: Induction of spermatogenesis in infertile men with primary and secondary hypogonadotropic hypogonadism for whom the cause of infertility is not due to primary testicular failure. ( 1.3 ) 1.1 Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure. 1.2 Development of multiple follicles in ovulatory infertile women as part of an assisted reproductive technology (ART) cycle. 1.3 Induction of spermatogenesis in infertile men with primary and secondary hypogonadotropic hypogonadism for whom the cause of infertility is not due to primary testicular failure.

Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.