Otsuka America Pharmaceutical, Inc. FDA Approvals

0 new drug approvals and 3 device clearances on file. Matched by name to OTSKY.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Otsuka Digital Feedback Device510(k)Jun 30, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jun 30, 2025
Rejoyn510(k)Mar 30, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 30, 2024
Otsuka Digital Feedback Device-RW510(k)Aug 11, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 11, 2023