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FDAAA added a section, 505 (u), to allow sponsors to claim 5-year NCE exclusivity for a single enantiomer of a marketed racemic drug, under certain conditions:
- Is there any precedent of the approval of a drug using 505(u) since the enactment of FDAAA in 2007?
- On a related note, I know a single enantiomer drug of a previously approved racemic mixture received approval using the 505(b)(2) pathway a couple of years ago. The only clinical study in the package was a BE, so the label is identical to the racemic drug in efficacy and safety claims. Compared to 505(b)(1), the savings in time and development costs are obvious. That said, are there any commercial reasons for a sponsor to develop something that is essentially a single enantiomer generic of a racemic drug?