A spearmint-flavored, chewable formulation of a combination oral contraceptive already on the market was approved last month by the Food and Drug Administration.
The new product, which is a chewable version of Ovcon 35, will not be available until the spring, according to a spokesperson for Warner-Chilcott, which will market the chewable OC under the same trade name.
Both formulations contain 0.4 mg of norethindrone and 35 [mu]g of ethinyl estradiol. The new product "'provides one more alternative to the many types of oral contraceptives on the market," the FDA said in a short statement announcing this approval.
The pills can be swallowed whole or chewed and then swallowed. Women who chew the pills must then drink 8 ounces of liquid "immediately afterwards so that the full dose of medication reaches the stomach and no residue is left in the mouth," the FDA said.
The standard OC risks and warnings pertain to this product.
The chewable version will be available in a 28-day regimen. Each package will contain 21 white pills containing the progestin and estrogen and 7 green inert tablets to complete the 4-week cycle, the FDA said.
The price of the new product is expected to be about the same as the currently marketed version of Ovcon 35.
Warner-Chilcott, based in Rockaway, N.J., is owned by the Irish pharmaceutical company Galen Holdings. Ovcon 35 is manufactured by Bristol-Myers Squibb.
COPYRIGHT 2003 International Medical News Group
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