Can you earn more than one 6-month period of pediatric exclusivity?
Response to the Written Request is a supplement for a new use.
A new use is a use that is not included in the approved labeling of an approved drug, including a new pediatric population.
The supplement qualifies for 3-year Waxman-Hatch exclusivity
The 6-month period of pediatric exclusivity attaches only to the 3-year exclusivity.