Transcription of Gonal-f - Food and Drug Administration
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Gonal-f - Food and Drug Administration
NDA 20-378/S-015 Page 3 Gonal-f (follitropin alfa for injection) For subcutaneous injection DESCRIPTION Gonal-f (follitropin alfa for injection) is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the - and -subunits. The - and -subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structure are indistinguishable from those of human follicle stimulating hormone. Recombinant FSH production occurs in genetically modified Chinese Hamster Ovary (CHO) cells cultured in bioreactors.
NDA 20-378/S-015 Page 3 Gonal-f (follitropin alfa for injection) For subcutaneous injection DESCRIPTION Gonal-f (follitropin alfa for injection) is a human …
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