Merck Serono International S A
Merck Serono Submits Application for GONAL-f in Japan for Ovulation Induction in Infertile Women
Published in Medical Letter on the CDC and FDA, November 9th, 2008
announced that it has submitted a supplemental New Drug Application
(sNDA) to the Japanese Ministry of Health, Labor and Welfare for a new indication of GONAL-f(R) / GONALEF(R) (follitropin alfa for injection) for ovulation induction in infertile women. The sNDA submission is supported by a Phase III single-blinded controlled study conducted in Japanese women with no or irregular ovulation (anovulation or oligoovulation), including Polycystic Ovary Syndrome, which demonstrated the efficacy and safety of GONAL-f(R).
"The submission of GONAL-f(R) in Japan for female...
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