From 2001 to 2011, the US Food and Drug Administration approved 9 single-enantiomer drugs with racemic precursors. None showed pre-approval evidence of improved efficacy over the racemic precursor. We ...
Single-enantiomer drugs account for nearly 40% of the global pharmaceutical market. The author analyzes the current market for single-enantiomer drugs, their role as a generic drug defense strategy, ...