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

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