Novartis To Pull Valturna From U.S. Market As FDA Warns Of Risks With Aliskiren Meds
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA warns that use of aliskiren-containing blood pressure drugs with ACE inhibitors or angiotensin receptor blockers may increase risk of kidney impairment, hypotension and hyperkalemia; Novartis to continue to sell four other aliskiren products.
You may also be interested in...
NME Exclusivity Petitions Expand; Ferring Request For Colon-Cleansing Combo Has Urgency
Ferring requests five years of marketing exclusivity for Prepopik; Gilead also has asked FDA to award five years of exclusivity for active ingredients in a combination product that has not been previously approved, but Gilead has patents to fall back on while Ferring has none.
EU And U.S. Regulators Toughen CV Monitoring Requirements For Novartis's Gilenya
A review of a potential association between Novartis's oral multiple sclerosis therapy Gilenya and sudden death was inconclusive, say EU regulators, but monitoring requirements are still strengthened as a precaution.
EU And U.S. Regulators Toughen CV Monitoring Requirements For Novartis's Gilenya
A review of a potential association between Novartis's oral multiple sclerosis therapy Gilenya and sudden death was inconclusive, say EU regulators, but monitoring requirements are still strengthened as a precaution.