Simplifying Global Compliance
FDAnews Drug Daily Bulletin
Analysts See More FDA Concerns With Constipation Drugs Post-CRL
Aug. 8, 2012
The FDA’s recent complete response letter (CRL) on Salix’s sNDA for opioid-induced constipation (OIC) drug Relistor likely cites safety concerns and signals increased scrutiny for all makers of these drugs, analysts say. The agency may be cautious about a cardiovascular class-effect in mu-receptor antagonist candidates such as Relistor (methylnaltrexone bromide), Cantor Fitzgerald analyst Irina Rivkind writes.
Washington Drug Letter
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