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acgood

08/27/12 8:31 PM

#147781 RE: biomaven0 #147778

It's also the case that the FDA has gotten much tougher on names that can be mistaken (in either speech or writing) for existing names, and also don't want names that may suggest efficacy.



This is quite true. Lipitor would be rejected if submitted today
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DewDiligence

08/27/12 8:48 PM

#147782 RE: biomaven0 #147778

…FDA has gotten much tougher on names…that may suggest efficacy.

This policy has been in effect for a long time. For instance, Upjohn wanted to name their anti-baldness drug Regaine and the FDA made them change it to Rogaine. That was in 1988.
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DewDiligence

10/04/12 9:42 PM

#150055 RE: biomaven0 #147778

Just realized that Prevnar/Prevnar 13 may be another instance in which the FDA tweaked the name to eliminate any hint of implied efficacy. The brand name in Europe is Prevenar and that extra “e” gives the name a rather different ring.