U.S. License Holder:
Date of License:
Women: GONAL-F (follitropin alfa for injection) is indicated for: The induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure; The development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.
Men: GONAL-F (follitropin alfa for injection) is indicated 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.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In The E.U.
Bemfola (Finox Biotech) (March-2014)Ovaleap (Teva Pharma) (September-2013)
Biosimilars Approved In Australia
Bemfola / Afolia (Gedeon Richter) (November-2015)