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Merck Serono files sNDA for new indication of infertility drugOct 27, 2008 (Datamonitor via COMTEX) -- Merck Serono, a division of Merck KGaA, has submitted a supplemental new drug application to the Japanese Ministry of Health, Labor and Welfare for a new indication of Gonal-f/Gonalef for ovulation induction in infertile women. The supplemental new drug application (sNDA) submission is supported by a Phase III single-blinded controlled study conducted in Japanese women with no or irregular ovulation, including polycystic ovary syndrome, which demonstrated the efficacy and safety of Gonal-f. The sNDA submission file includes three presentations of Gonal-f in a prefilled pen, for ready-to-use self-injection, designed to improve treatment convenience and accurate dosage delivery (Gonal-f prefilled pen 300IU, 450IU, 900IU). The Gonal-f prefilled pen is specifically designed for infertility treatment and allows for multidose presentations. The sNDA file also includes Gonal-f in 75IU vial presentation. Franck Latrille, executive vice president head of commercial international at Merck Serono, said: "The submission of Gonal-f in Japan for female infertility confirms our company's commitment to provide patients with a full portfolio of infertility medications for every stage of the reproductive cycle. When approved, women in Japan would have access to the leading recombinant human follicle-stimulating hormone delivered in the only ready-to-use pre-filled pen available on the market, to help them build families." http://www.datamonitor.com Republication or redistribution, including by framing or similar means, is expressly prohibited without prior written consent. Datamonitor shall not be liable for errors or delays in the content, or for any actions taken in reliance thereon |