azelaic acid .15 g/g
azelaic acid · GEL · Actavis Pharma, Inc.
azelaic acid is a gel containing azelaic acid at .15 g/g, taken topical. Manufactured by Actavis Pharma, Inc..
Key Facts
- Brand Name
- azelaic acid
- Generic Name
- azelaic acid
- NDC Code (Product)
0591-2131- Manufacturer
- Actavis Pharma, Inc.
- Strength
- .15 g/g
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA208011
- Marketing Start
- 11/19/2018
Recall History
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Market complaints received for gritty texture (grainy)
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
API Solutions Inc.
cGMP Deviations
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of Use Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea ( 1 ). Limitations of Use Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Cleanse affected area(s) using only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before application of azelaic acid gel. • Apply and gently massage a thin layer of azelaic acid gel into the affected areas on the face twice daily (morning and evening). • Wash hands immediately following application of azelaic acid gel. • Cosmetics may be applied after the application of azelaic acid gel has dried. • Reassess the diagnosis if no improvement is observed upon completing 12 weeks of therapy. • Avoid the use of occlusive dressings or wrappings. • Instruct patients to avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. • For topical use. • Not for oral, ophthalmic or intravaginal use. • Apply a thin layer twice daily to affected area(s). ( 2 ) • Use only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before applying azelaic acid gel. ( 2 ) • Wash hands immediately following application. ( 2 ) • Cosmetics may be applied after the application of azelaic acid gel has dried. ( 2 ) • Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling age…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions are burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two vehicle-controlled and one active-controlled U.S. clinical trials, treatment safety was monitored in 788 subjects who used twice-daily azelaic acid gel for 12 weeks (N=333) or 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks. In all three trials, the most common treatment-related adverse events were: burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). In the active-controlled trial, overall adverse reactions (including burning, stinging/tingling, dryness/tightness/scaling, itching, and erythema/irritat…
Frequently Asked Questions
What is azelaic acid used for?
azelaic acid contains azelaic acid. It is a gel taken topical. Consult your doctor for specific uses.
Is azelaic acid a controlled substance?
azelaic acid is not classified as a controlled substance by the DEA.
What is the generic name for azelaic acid?
The generic name for azelaic acid is azelaic acid. There are 8 other brand versions of azelaic acid.
What is the NDC code for azelaic acid .15 g/g?
The NDC (National Drug Code) for azelaic acid .15 g/g is 0591-2131, listed by Actavis Pharma, Inc..