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News Breaks
July 14, 2014
07:07 EDTPGNX, SLXPFDA says RELISTOR can be approved on data submitted in sNDA
Salix Pharmaceuticals (SLXP) and Progenics Pharmaceuticals (PGNX) announced that the Food and Drug Administration has informed Salix that RELISTOR can be approved on the data submitted in the sNDA. The FDA Office of Drug Evaluation III responded to the company’s formal appeal filed in response to the Complete Response Letter of July 27, 2012 to the supplemental NDA ) for RELISTOR. The Agency’s letter stated that, “Salix’s request that FDA approve the supplemental NDA for RELISTOR subcutaneous injection for the treatment of opioid-induced constipation in patients with chronic non-cancer pain based on the submitted data is granted.” This request for a proposal for a post-marketing observational study is in accordance with recommendations of the June 11-12, 2014 meeting of the Anesthetic and Analgesic Drug Product Advisory Committee. Salix will work with the DGIEP in an effort to provide information to the division that will enable the division to approve RELISTOR for use by patients with chronic non-cancer pain and experiencing OIC.
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April 24, 2015
09:18 EDTPGNXValeant and Progenics' Relistor eceives positive opinion from EMA
Valeant (VRX) and Progenics (PGNX) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending a new indication for Relistor Subcutaneous Injection for the treatment of opioid-induced constipation when response to laxative therapy has not been sufficient in adult patients, aged 18 years and older. Additionally, the Committee has recommended a one-year extension of data/marketing protection for Relistor, to 11 years from the date of approval.

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