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Toremifene FDA Approval Status

FDA Approved: No
Generic name: toremifene
Company: GTx, Inc.
Treatment for: Prevention of Fractures

Toremifene is an investigational oral selective estrogen receptor modulator for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy.

In November 2009, GTx, Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for toremifene had not been approved.

Development timeline for toremifene

Nov  2, 2009GTx Receives Complete Response Letter from FDA for Toremifene 80 mg New Drug Application
Mar  5, 2009FDA Provides PDUFA Target Agency Action Date For GTx's Toremifene 80 mg NDA
Feb 18, 2009GTx Announces Toremifene 80 mg NDA Accepted for Review by FDA
Dec 30, 2008GTx Submits New Drug Application for Toremifene 80 mg for the Prevention of Bone Fractures in Men with Prostate Cancer on Androgen Deprivation Therapy

Further information

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