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US FDA accepts Merck's corifollitropin alfa NDa for fertility treatment
Whitehouse Station, New Jersey | Tuesday, September 10, 2013, 14:00 Hrs  [IST]

The US Food and Drug Administration (FDA) has accepted for standard review of Merck's New Drug Application (NDA) for investigational fertility treatment, corifollitropin alfa.  Merck is seeking FDA approval of corifollitropin alfa for Controlled Ovarian Stimulation (COS) in women participating in assisted reproductive technology.

If approved, corifollitropin alfa would be the first sustained follicular stimulant for use in a fertility treatment regimen.

“Infertility is an issue faced by many couples in the United States,” said Barbara Stegmann, M.D., reproductive endocrinology and infertility specialist, and principal scientist and clinical lead fertility, Merck. “The filing of corifollitropin alfa is an example of Merck’s commitment to patients and scientific innovation. We thank the patients and physicians who have participated in the clinical trials that are so essential to developing innovative fertility treatment options.”

Merck’s corifollitropin alfa is currently approved in more than 50 markets outside the United States, including the European Union.

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada.

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