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Fertinex highly purified FSH is Serono's second Aug. 23 approval.

Executive Summary

SERONO FERTINEX HIGHLY-PURIFIED FSH can be injected subcutaneously, allowing for greater patient benefit than Serono's follicle-stimulating hormone Metrodin, which must be injected intramuscularly, the company said. Urofollitropin for injection purified was approved Aug. 23 for use in combination with hCG to stimulate fertility. Serono filed sNDA 19-415/S-009 on April 30, 1992. FDA approved purified FSH after issuing two "not approvable" letters for the drug.

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