Cytotec Relabeling Adds Labor Section; Mifeprex “Dear Doctor” Letter Sent
FDA is requiring Pharmacia to re-label Cytotec (misoprostol) to reflect use with Danco's Mifeprex without explicitly addressing the abortifacient regimen
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FDA is continuing to negotiate with Searle regarding changes to labeling of its gastric ulcer treatment Cytotec (misoprostol), which is an essential component of the recently approved Mifeprex (mifepristone, RU-486) regimen for termination of pregnancy.
"Special considerations" boxed warning added to misoprostol labeling in order to strengthen contraindication in pregnancy. Labeling has also been updated to include reports of serious adverse events associated with use of Cytotec in pregnant women (1"The Pink Sheet" Aug. 28, p. 14)
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011