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Re: dmiller post# 297034

Sunday, 09/06/2020 11:33:08 PM

Sunday, September 06, 2020 11:33:08 PM

Post# of 401366
An actual, real answer, dmiller, could be yes. An Upjohn inventor, Anthony, appealed a PTO Board decision that was heard by the CCPA ~ 50 years ago. In what appeared then to be a once in a lifetime case, Upjohn became aware of safety concerns relating to one of its drugs(Monase?) that had been administered to many thousands of patients. Upjohn presented AE evidence to the FDA that a small number(~ 12) of those patients developed a potentially fatal agranulocytosis. The FDA suspended/withdrew its approval of Upjohn’s NDA for Monase on safety grounds, pending its further investigation of safety of the drug. I posted a link to that case here(?) months ago. You can find the link for the rest of the story.

Amarin has noted that pancreatitis develops in some of the patients taking Vascepa who have trigs > 500 mg/dL

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