FDA Approves Vaniqa (Eflornithine Hydrochloride) 13.9% For Women With Unwanted Facial Hair
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FDA Approves Vaniqa (Eflornithine Hydrochloride) 13.9% For Women With Unwanted Facial Hair

NEW YORK, NY -- August 1, 2000 -- Bristol-Myers Squibb Company and The Gillette Company announced that the Food and Drug Administration has approved Vaniqa® (eflornithine hydrochloride) Cream, 13.9% as the first topical prescription treatment for women with unwanted facial hair.

Vaniqa works by inhibiting the growth of facial hair, and was shown in clinical trials to provide clinically meaningful and statistically significant improvement in the reduction of facial hair growth in women.

More than 41 million women in the U.S. have unwanted facial hair, a condition that can affect women of all ages, races and ethnic backgrounds. In most cases, unwanted facial hair is caused by hereditary factors. In clinical trials, among those who completed 24 weeks of treatment, nearly 60 percent of patients using Vaniqa improved. Significant differences between Vaniqa and vehicle were seen as soon as eight weeks into treatment. Along with Vaniqa, women should continue to use their current method of hair removal. Vaniqa is available by prescription and should be in pharmacies in early September.

In clinical trials, if side effects occurred, they were mild and generally resolved without treatment. The most common side effects associated with Vaniqa were minor skin irritations such as temporary redness, hair bumps, stinging, burning, tingling, acne, or rash.

Related Link: Bristol-Myers Squibb Company.

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