Ortho's Low-Dose OC Cleared For Acne In USA

13 January 1997

Ortho Pharmaceutical's Ortho Tri-Cyclen tablets(norgestimate/estradiol) has been approved by the US Food and Drug Administration for the treatment of acne in women seeking contraception. It is said to be the first time an oral contraceptive has been cleared by the US regulatory authorities for such therapy, and the first low-dose birth control pill to be cleared for a noncontraceptive indication since the Pill was introduced over 35 years ago.

According to Ortho, in clinical trials, Ortho Tri-Cyclen showed improvement of acne similar to that seen in studies looking at the efficacy of benzoyl peroxide and topical or systemic antibiotics. Two randomized, double-blind, placebo-controlled studies demonstrated that improvement of acne was reported during use of Ortho Tri-Cyclen in more than 80% of the studies' participants.

"This is great news for the millions of women with acne who take or want to take birth control pills," according to Geoffrey Redmond, president of the Foundation for Developmental Endocrinology. These studies, he added, "suggest that Ortho Tri-Cyclen treats acne at its source by decreasing the level of hormones that contribute to the development of acne."

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