Fda pediatric exclusivity duration?

Question

Accepted Answer

Duration: six months.
How it’s granted: if a sponsor conducts pediatric studies in response to a FDA Written Request under the Best Pharmaceuticals for Children Act (BPCA) and the FDA determines the studies meet the requirements.
Effect: adds six months to the drug’s period of market protection (the end date of the existing patent/exclusivity). It cannot extend beyond the expiration of the patent or other applicable exclusivities.
Note: A labeling change can occur, but the 6-month extension itself is independent of labeling.

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