CBER 2025 Orphan Approvals (new BLAs)

This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval in reverse chronological order.Trade Name/Proper...

Natuzen Co., Ltd. – 677942

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Seunghyun Cho Recipient Title General Manager Natuzen Co., Ltd. 289 Namdongdong-RoNamdong-guIncheon21639South Korea Issuing Office: Center for Drug Evaluation and Research | CDER United States...