Matthew Herper says: Europe approves Merck's niacin/flush-blocker combo pill, called Tredaptive. The U.S. brand name was meant to be Cordaptive, but Merck has told Wall Street the U.S. Food and Drug Administration wants a lot more data, delaying re-submission as much as five years. It would be interesting to know why European and U.S. regulators don't see eye-to-eye, but unfortunately the regulatory process is pretty opaque. And everybody is left guessing. |
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