FDA Clears Wyeth-Ayerst's Alesse

6 April 1997

Wyeth-Ayerst Laboratories, a division of American Home Products, hasreceived approval from the US Food and Drug Administration to market Alesse, a low-dose oral contraceptive.

When launched, Alesse, comprising 100mcg levonorgestrel and 20mcg ethinyl estradiol, will be the lowest dose of this hormone combination on the US market, according to the company.

"Low Drop-Out Rates" In clinical trials with 1,477 patients, Alesse demonstrated that, like other oral contraceptives, it is more than 99% effective for birth control. In addition, drop-out rates for pill-associated side effects were very low.

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