Wednesday, December 1, 2010

Merck's Proscar® For Prostate Cancer "Not Recommended": 17-0, At FDA Panel

Not really surprising -- given the tenor of the remarks of the FDA staff, this morning. In any event, here is the detail on Proscar® (finasteride) portion of today's meeting, from a Bloomberg story on it:

. . . .Outside advisers to the Food and Drug Administration voted 17-0 with one abstention today that Proscar has an unfavorable balance of risks and benefits in healthy men at least 55 years old. Merck, based in Whitehouse Station, New Jersey, asked to add data from its studies in prostate cancer to the prescribing information for Proscar, approved in 1992. . . .

Wow -- 17-0, huh? -- a complete shutout. So it goes.

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