FDA Approves First Chewable Oral Contraceptive Tablet

Last Editorial Review: 11/17/2003

Nov. 14, 2003 -- The FDA today approved Ovcon 35, an oral, spearmint-flavored contraceptive tablet that can be chewed and swallowed. This new version of Ovcon 35, indicated for the prevention of pregnancy, provides one more alternative to the many types of oral contraceptives currently on the market. Ovcon 35 contains a progestin (norethindrone) and an estrogen (ethinyl estradiol) found in products that are already marketed.

The directions for use tell women that the pill may be swallowed whole or chewed and swallowed. If the pill is chewed and then swallowed, the woman should drink a full glass (8 ounces) of liquid immediately afterwards so that the full dose of medication reaches the stomach and no residue is left in the mouth.

Ovcon 35 is available only in a 28-day regimen. Each package contains 21 round, white tablets, with norethindrone and ethinyl estradiol followed by seven reminder green (inactive) tablets to complete a 4-week-cycle.

Like other birth control pills, Ovcon 35 is effective for prevention of pregnancy when used as directed. The risks of using this product are similar to those of all birth control pills and include an increased risk of blood clots, heart attack, and stroke. The labeling also carries the warning that cigarette smoking by women, especially over age 35 increases the risk of serious cardiovascular side effects from use of combination hormonal contraceptives.

The product is manufactured by Bristol Myers Squibb Company, Princeton, N.J., and will be marketed by Warner Chilcott, Inc., Rockaway, N.J.

Source: U.S. Food & Drug Administration Press Release #T03-74, November 14, 2003

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