Wyeth/Progenics’ Relistor: FDA Says Yes, EU Likes It, Too
This article was originally published in The Pink Sheet Daily
Executive Summary
Compound helps bowel function in dying patients on opioids.
You may also be interested in...
Relistor Expansion Plans In Question Following “Complete Response” Letter
FDA requested more clinical data on Salix/Progenics’ sNDA for approval of the subcutaneous formulation of methylnaltrexone in chronic, non-cancer pain patients with opioid-induced constipation. The regulatory setback could have implications for the companies’ planned September filing of an oral formulation in the same patient population.
Relistor Expansion Plans In Question Following “Complete Response” Letter
FDA requested more clinical data on Salix/Progenics’ sNDA for approval of the subcutaneous formulation of methylnaltrexone in chronic, non-cancer pain patients with opioid-induced constipation. The regulatory setback could have implications for the companies’ planned September filing of an oral formulation in the same patient population.
Relistor Expansion Plans In Question Following “Complete Response” Letter
FDA requested more clinical data on Salix/Progenics’ sNDA for approval of the subcutaneous formulation of methylnaltrexone in chronic, non-cancer pain patients with opioid-induced constipation. The regulatory setback could have implications for the companies’ planned September filing of an oral formulation in the same patient population.