Mon 17 Nov 2003
The FDA on Friday approved a spearmint-flavored chewable version of Northern Ireland-based Galen Holdings’ oral contraceptive Ovcon 35, the Baltimore Sunreports (Baltimore Sun, 11/15). The pill is the first chewable oral contraceptive pill for women, according to an FDA release. The chewable pills, which Bristol-Myers Squibb will manufacture and Rockaway, N.J.-based Warner Chilcott will market, contain progestin and estrogen — the same hormones used in standard birth control pills. The pills will be available in a 28-day regimen with 21 white tablets containing norethindrone and ethinyl estradiol and seven green placebo pills that induce a menstrual period (FDA release, 11/14). Women will be able to chew the pills or swallow them whole; women who chew the pills must drink an eight-ounce glass of water afterward to ensure that the full dose reaches their stomachs. The chewable version of Ovcon 35 has similar side effects to other birth control pills, such as an increased risk for blood clots, heart attack and stroke, Reuters reports (Reuters, 11/14). (via Daily Reproductive Health Report)