SYNOJOYNT
FDA premarket approval P170016 · decided 2018-05-08
Approval details
- PMA number
- P170016
- Trade name
- SYNOJOYNT
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Mesoblast
- Date received
- 2017-05-15
- Decision date
- 2018-05-08
- Days to decision
- 358 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Melbourne
- Statement
- Approval for SYNOJOYNT. SYNOJOYNT is indicated for use in the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen).
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