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For approved drugs, must FDA approve a supplemental application before pediatric exclusivity is granted?

April 26, 2017application approve Approved drugs exclusivity fda GRANTED pediatric supplemental

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For approved drugs, must FDA approve a supplemental application before pediatric exclusivity is granted?

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A9. No. The granting of exclusivity is not connected to approval; the pivotal factor is whether the applicant complied with the terms of the Written Request.