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Re: roadkilll post# 351527

Sunday, 08/22/2021 12:50:10 PM

Sunday, August 22, 2021 12:50:10 PM

Post# of 425975
You can't change the name of your drug after the FDA approves the NDA, except when the drug is modified to act differently, like an extended release version, and you put a suffix on the end of the existing name - Wellbutrin XL, for instance (the drug where generic was determined to not be equivalent to brand), or Adderall XR. Can't change the label to remove the TG's > 500 indication either, that's still a valid use of V and accounts for ~ 10% of sales. That's why V is protected from generic attacks in the EU - V is not approved there for TGs >500, indication is not on the label.

The Thought Police: To censor and protect. Craig Bruce

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