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Relistor FDA Approval History

FDA Approved: Yes (First approved April 25, 2008)
Brand name: Relistor
Generic name: methylnaltrexone bromide
Dosage form: Tablets and Subcutaneous Injection
Company: Salix Pharmaceuticals, Inc.
Treatment for: Constipation

Relistor (methylnaltrexone) is a peripherally acting mu-opioid receptor antagonist indicated to treat opioid-induced constipation.

Development timeline for Relistor

Jul 19, 2016Approval Valeant and Progenics Announce FDA Approves Relistor Tablets for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-Cancer Pain
Apr 25, 2008Approval Progenics and Wyeth Announce FDA Has Approved Relistor
Jan 10, 2008Progenics and Wyeth Announce NDA Review Period for Subcutaneous Methylnaltrexone Extended by Three Months
May 31, 2007Progenics and Wyeth Announce FDA Has Accepted For Filing the New Drug Application for Subcutaneous Methylnaltrexone
Mar 30, 2007Progenics and Wyeth Announce Submission of New Drug Application for the Subcutaneous Formulation of Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Patients Receiving Palliative Care

Further information

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