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In this section: NDA and BLA Approvals

Breakthrough Therapy Approvals

The CDER Breakthrough Therapy (BT) Approvals reports contain a list of approvals for breakthrough therapy designated drugs. New reports will be published quarterly for the current calendar year (CY).

Approvals

Current CY CDER BT Approvals (PDF - 106 KB)
Previous Cumulative CY CDER BT Approvals (PDF - 304 KB)

Related Information

Frequently Asked Questions: Breakthrough Therapies
Fact Sheet: Breakthrough Therapies

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