Topical Cocaine Provides US FDA With First Case Of ‘Dueling’ 505(b)(2) NDAs

Lannett and Genus’s battle parses the distinction between NMEs and NCEs and the meaning of US Hatch-Waxman exclusivity.

Wild-west-duel
The FDA is not aware of another set of ‘dueling’ 505(b)(2) applications since 1984." • Source: Shutterstock

More from United States

More from North America