Table 2.

Regulatory Origins of the “Pediatric” Studies in Antidepressants.

Compound FDA EMA
Duloxetine FDA WR34
Brexanolone FDA WR35
Vortioxetine FDA PREA36 PIP EMEA-000455-PIP02-10-M0437
Levomilnacipran FDA PREA38
Esketamine PIP EMEA-001428-PIP03-1539

PIP, pediatric investigation plan; PREA, pediatric research equity act: mandatory demand for pediatric studies; WR, written request: voluntary request that results in patent extension upon execution of the requested studies.

RMMJ Rambam Maimonides Medical Journal Rambam Health Care Campus 2019 October; 10(4): e0026. ISSN: 2076-9172
Published online 2019 October 29. doi: 10.5041/RMMJ.10374