Home » Drug Information » FDA-Approved Drugs » 2001
Medical Areas: Dermatology/Plastic Surgery
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Berlex Laboratories
Approval Status: Approved May 2001
Treatment Area: Acne
FINEVIN, a twice-daily topical azelaic acid cream, has been
approved for the treatment of mild to moderate acne vulgaris. It is
the second azelaic acid product available in the United States and
represents a cost-effective and well-tolerated acne treatment.
Acne affects more than 17 million people in the United States
and is the most common skin condition treated by physicians. Acne
vulgaris, or common acne, is a disease that affects the sebaceous
glands of the skin, resulting in inflammatory and/or
non-inflammatory lesions.
Clinical studies with FINEVIN in both the United States and
Europe have shown the drug to be effective in treating mild to
moderate acne. FINEVIN demonstrated antimicrobial activity against
Propionibacterium acnes and Staphylococcus epidermis, normalized
the follicular hyperkeratosis associated with acne, and produced
anti-inflammatory effects. In the majority of patients,
improvements in acne were seen within four weeks of beginning
treatment.
Adverse events associated with the use of azelaic acid cream may
include (but are not limited to) the following:
- Pruritus
- Burning
- Stinging
- Tingling
The exact mechanism of action of FINEVIN (azelaic acid cream) is
unknown. The antimicrobial action of azelaic acid may be attributed
to inhibition of microbial cellular protein synthesis.
For additional information on FINEVIN, please visit
Berlex.
