CRL
Celltrion Inc.FDA CRL - Celltrion Inc.
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Record Details
The FDA issued a Complete Response Letter (CRL) to CELLTRION, Inc. for its Biologics License Application (BLA) 761088 for CT-P10, a proposed biosimilar to US-licensed Rituxan. The application cannot be approved in its present form due to unresolved deficiencies identified during a recent manufacturing facility inspection, significant clinical study concerns, and numerous product quality issues.
- Company
- Celltrion Inc.
- Product Type
- Bla
- Person
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ID · 0763a33e-2365-43bd-9c70-1bdec22e4f9c