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A position that adrafinil is an unapproved drug was indicated in a warning letter [1] by the FDA in 2019: “Your [particular] products [subject to this warning] [including] Adrafinil…are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are 'new drugs' under section 201(p) of the Act.
Besides their potential medical use, modafinil analogues, including adrafinil, flmodafinil, fladrafinil, and modafiendz, are also sold online as substances that are believed to improve cognitive functions such as memory and focus (nootropics or "cognitive enhancers"). [1] [9] [10] [11]
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[1] [5] [11] Chemically, armodafinil is the enantiopure (R)-(–)-enantiomer of the racemic mixture modafinil (brand name Provigil). [ 1 ] [ 4 ] [ 5 ] Both enantiomers of modafinil are active as DRIs and wakefulness-promoting agents, but armodafinil is more potent and longer-acting.
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