Biotech Values

[bladerunner1717]

Mouton and Zipjet,

What are the criteria by which the FDA determines whether a drug is "fully substitutable" or not? How are those criteria different from a drug approved as a "not fully substitutable" generic?

If a drug is approved as a generic, but not a "fully substitutable" generic, then how do we refer to this drug (as opposed to how we would refer to the fully substitutable drug)? Branded generic?

Does a drug that is approved as a generic, but not a "fully substitutable" generic have to undergo any clinical testing?

Do you happen to know whether the generics approved for Wellbutrin XL were approved as fully substitutable or not?

Would a physician be less likely to prescribe a generic drug, if s/he knew that the drug had been approved as a "not fully substitutable" drug?

Does a patient generally know whether a generic has been approved as "fully substitutable" or "not fully substitutable?" (I understand that a pharmacist can fill the prescription anyway that s/he wants, if the drug has been approved as "fully substitutable." I assume the treating physician can write the prescription for the branded original, if s/he has any doubts about the efficacy and/or safety of the approved generic, whether it's been approved as "fully substitutable" or not.)


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