Merck Gets A “No” From FDA — On Latest Label Expansion From IMPROVE-IT Data

A few weeks ago, I mentioned that this proposed new indication was voted down by the Advisory Committee at FDA — and wondered aloud whether an ex-Merck officer’s new role as Senior Counsel to the Commissioner might lead to mischief, in the form of an approval at the full Commission level.

I can safely report that it has not.

The full Commission has voted not to grant the label expansion. I’d guess that just cost Kenilworth about an annual $50 million in sales in the US. Immaterial, but a strange end to a twisted ten year tale.

So it goes.

Onward.

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