FoundationOne CDx
FDA premarket approval P170019/S004 · decided 2019-07-01
Approval details
- PMA number
- P170019
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2018-09-24
- Decision date
- 2019-07-01
- Days to decision
- 280 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval order for extending the label claim to include an indication for LYNPARZA (olaparib) in ovarian cancer patients with BRCA1/2 alterations.
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