Otsuka Pharmaceutical Development & Commercialization, Inc.
Overview
Otsuka Pharmaceutical Development & Commercialization, Inc. is a subsidiary of Otsuka Pharmaceutical Co., Ltd., focused on the development, clinical research, and commercialization of pharmaceutical products. The company is known for its innovative therapies in the mental health and kidney disease domains.
Therapeutic areas
FDA compliance signals
4 FDA enforcement records linked to this company.
- recall — Class III2018-10-10
Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
- recall — Class III2018-10-10
Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
- 4832014-03-18
Submission of report follow-up
- 4832014-03-18
Late submission of 15-day report
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