HYALGAN
FDA premarket approval P950027/S009 · decided 2008-05-01
Approval details
- PMA number
- P950027
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HYALGAN
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Fidia Farmaceutici S.P.A.
- Date received
- 2007-06-20
- Decision date
- 2008-05-01
- Days to decision
- 316 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Abano Terme
- Statement
- APPROVAL FOR THE MODIFICATION OF THE MANUFACTURING PROCESS FOR HYALGAN FOR PRODUCING HYALURONATE BY A BACTERIAL FERMENTATION AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY, AND TO SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HyaloGYN Vaginal Moisturizing Suppositories (K191052) | Fidia Farmaceutici S.P.A. | 2020-01-09 |
| HyaloGYN Vaginal Hydrating Gel (K150883) | Fidia Farmaceutici S.P.A. | 2015-09-01 |
| HYALO GYN (K094039) | Fidia Farmaceutici S.P.A. | 2010-05-07 |