Overview
Fluocinolone acetonide, with the formula 6-alpha, 9-alpha-difluoro-16-alpha, 17 alpha-acetonide, is a corticosteroid that presents a high lipophilicity. It has been used extensively in dermatological preparations and it has also been investigated thoroughly for its use in implantable corticosteroid devices. This type of device containing fluocinolone acetonide was developed by Taro Pharmaceuticals and approved by FDA in May 2016.
Background
Fluocinolone acetonide, with the formula 6-alpha, 9-alpha-difluoro-16-alpha, 17 alpha-acetonide, is a corticosteroid that presents a high lipophilicity. It has been used extensively in dermatological preparations and it has also been investigated thoroughly for its use in implantable corticosteroid devices. This type of device containing fluocinolone acetonide was developed by Taro Pharmaceuticals and approved by FDA in May 2016.
Indication
Fluocinolone acetonide has been used extensively in different medical areas. -In dermatology, it is extensively used for the relief of inflammatory dermatosis, dermatitis, psoriasis, hypertrophic tissues, keloid tissues and atopic dermatitis. -It has been used in shampoo products as a low to medium potency corticosteroid for the treatment of seborrheic dermatitis of the scalp. -In ear drops, it is used as a low to medium potency corticosteroid for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older. -As an intravitreal implant, it is indicated for the treatment of diabetic macular edema with patients that have been previously treated with a course of corticosteroids and no clinically significant rise in intraocular pressure. -Fluocinolone acetonide was announced on October 15, 2018 to be FDA approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. -Some reports have indicated the use of fluocinolone acetonide as a vasoprotective agent and for its use in the treatment of first-degree hemorrhoids.
Associated Conditions
- Acute Otitis Media (AOM)
- Allergic Skin Reaction
- Atopic Dermatitis
- Blisters
- Chronic Disease of Skin
- Dermatosis
- Diabetic Macular Edema (DME)
- External Hemorrhoid
- Fissure;Anal
- Friction and Pressure Injuries
- Hemorrhoids, Internal
- Non-infectious Posterior Uveitis Chronic Uveitis
- Otitis Externa
- Perianal erythema
- Pruritus
- Psoriasis of the scalp
- Purulent Wounds
- Scab
- Seborrheic dermatitis of the scalp
- Skin Inflammation caused by Bacterial Infections
- Skin Inflammation of the ear
- Uveitis
- Wound Infections
- Anal eczema
- Bacterial skin infections
- Chronic eczematous otitis externa
- Corticosteroid-responsive dermatoses
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/05/06 | Phase 3 | Recruiting | Jaeb Center for Health Research | ||
2022/10/25 | N/A | Recruiting | Tianjin Medical University | ||
2022/08/03 | Phase 3 | Recruiting | |||
2021/06/08 | Early Phase 1 | Active, not recruiting | Sanjay Asrani | ||
2020/07/14 | Phase 4 | Active, not recruiting | |||
2020/04/09 | N/A | Recruiting | |||
2018/12/21 | Phase 2 | Withdrawn | |||
2017/06/23 | Phase 3 | Completed | Salvat | ||
2016/09/16 | Phase 4 | Withdrawn | |||
2015/06/15 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 72162-1271 | TOPICAL | 0.1 mg in 1 mL | 3/11/2024 | |
| Bryant Ranch Prepack | 72162-1434 | TOPICAL | 0.01 mg in 100 mL | 3/12/2024 | |
| Royal Pharmaceuticals | 68791-101 | TOPICAL | 0.11 mg in 1 mL | 4/15/2018 | |
| Sincerus Florida, LLC | 72934-1083 | TOPICAL | 0.025 g in 100 g | 5/20/2019 | |
| Rising Pharmaceuticals, Inc. | 64980-329 | AURICULAR (OTIC) | 0.11 mg in 1 mL | 10/25/2018 | |
| Lupin Pharmaceuticals,Inc. | 43386-069 | TOPICAL | 0.1 mg in 1 mL | 2/21/2019 | |
| Amneal Pharmaceuticals LLC | 65162-703 | TOPICAL | 0.11 mg in 118.28 mL | 12/18/2023 | |
| Medimetriks Pharmaceuticals | 43538-940 | TOPICAL | 0.25 mg in 1 g | 1/10/2023 | |
| EyePoint Pharmaceuticals, Inc | 71879-136 | INTRAOCULAR | 0.18 mg in 1 1 | 12/13/2023 | |
| Amneal Pharmaceuticals LLC | 65162-702 | AURICULAR (OTIC) | 0.11 mg in 20 mL | 12/18/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FLUNOLONE-V CREAM 0.25 mg/g | ATLANTIC LABORATORIES CORPN LTD | SIN04897P | CREAM | 0.25 mg/g | 7/5/1990 |
| SUPRICORT CREAM 0.025% w/w | SIN03907P | CREAM | 0.025% w/w | 2/21/1990 | |
| TRI-LUMA CREAM | SIN12607P | CREAM | 0.1 mg/g | 10/19/2004 | |
| CETRAXAL PLUS EAR DROPS SOLUTION | SIN14597P | SOLUTION | 0.25mg | 8/29/2014 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| FLUOCINOLONE CREAM 0.0125% (VIDA) | N/A | N/A | N/A | 9/25/2000 | |
| FLUOCINOLONE ACETONIDE OINT 0.03% | N/A | N/A | N/A | 10/25/1986 | |
| CINO-N CREAM | N/A | N/A | N/A | 3/5/1987 | |
| SYNCO-CFN CREAM | N/A | N/A | N/A | 7/15/1993 | |
| NEO-CINOLONE CREAM | N/A | N/A | N/A | 5/18/1984 | |
| UNI-CINOLONE CREAM 0.025% | N/A | N/A | N/A | 10/14/1992 | |
| FLUOCINOLONE CREAM 0.0125% W/W | N/A | N/A | N/A | 7/13/2015 | |
| CATELONE-N CREAM | N/A | N/A | N/A | 3/5/1987 | |
| FLU-N CREAM | N/A | N/A | N/A | 5/19/1979 | |
| FLUOCINOLONE CREAM 0.025% (VIDA) | N/A | N/A | N/A | 9/25/2000 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ILUVIEN fluocinolone acetonide 190 mcg intravitreal implant in applicator | 306543 | Medicine | A | 8/6/2019 |