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Ridaforolimus FDA Approval Status

FDA Approved: No
Generic name: ridaforolimus
Company: Merck
Treatment for: Soft Tissue Sarcoma, Osteosarcoma

Ridaforolimus is an investigational oral mTOR inhibitor in development for the treatment of metastatic soft-tissue or bone sarcomas.

In June 2012, Merck & Co., 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 ridaforolimus had not been approved.

Development timeline for ridaforolimus

Jun  6, 2012Merck Receives Complete Response Letter from U.S. Food and Drug Administration for Investigational Medicine Ridaforolimus
Mar 21, 2012Merck and ARIAD Pharmaceuticals Provide Update on FDA Advisory Committee Vote on Investigational Medicine Ridaforolimus for the Treatment of Metastatic Soft-Tissue or Bone Sarcomas
Oct  5, 2011FDA Accepts New Drug Application Filing for Ridaforolimus, Investigational mTOR Inhibitor

Further information

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