Posted On: 07/20/2016 12:02:17 AM
Post# of 72440
Re: lousy.engineer #25609
Answer: most likely, yes. Prurisol is a prodrug of abacavir.
" a Phase III study is required for a 505(b)(2), such as when approval is sought for a prodrug of a previously approved active ingredient, only one study is often necessary versus the two generally required for 505(b)(1).
Fewer patients may be needed for 505(b)(2) product clinical trials due to the existing large exposure information available in the public literature or in the FDA’s databases
" a Phase III study is required for a 505(b)(2), such as when approval is sought for a prodrug of a previously approved active ingredient, only one study is often necessary versus the two generally required for 505(b)(1).
Fewer patients may be needed for 505(b)(2) product clinical trials due to the existing large exposure information available in the public literature or in the FDA’s databases
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