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Corifollitropin alfa FDA Approval Status

FDA Approved: No
Generic name: corifollitropin alfa
Company: Merck
Treatment for: Female Infertility

Corifollitropin alfa is a sustained follicular stimulant in development for use in a fertility treatment regimen.

In July 2014, Merck announced the receipt of a Complete Response Letter (CRL) from the U.S. FDA for its New Drug Application for corifollitropin alfa. Merck is evaluating the information provided in the CRL. Corifollitropin alfa is marketed as Elonva in more than 75 countries.

Development timeline for corifollitropin alfa

DateArticle
Jul 29, 2014Merck Receives Complete Response Letter from the U.S. FDA for New Drug Application for Corifollitropin Alfa
Sep  9, 2013Merck Announces FDA Acceptance of New Drug Application for Investigational Fertility Treatment

Further information

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