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12:00 AM
Mar 16, 2009
 |  BioCentury  |  Politics, Policy & Law

Waxman vs. Eschoo

Waxman vs. Eschoo

Waxman et al. Eshoo et al.
Initial data exclusivity Five years for new molecules, three years for a new biologic where a "major substance" in that new biologic had been approved previously. Exclusivity apparently only would be applied to biologics approved after enactment of the law. 12 years for all biologics.
Data exclusivity extension for new indication Six months for approval of a medically significant new application (reduced to three months if gross U.S. sales exceeded $1B for the year prior to approval of the new...

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