Gonal-f® (follitropin alfa/beta)

NDA 020378

Gonal-f® (follitropin alfa/beta)

NDA 020378

U.S. License Holder:

EMD Serono

Date of License:

September-29-1997

Last Update:

November-30-2018

approved_indications FDA-Approved Indications


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_indications 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 (Finox Biotech) (November-2015)

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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