Watson Pharmaceuticals receives FDA approval for oral contraceptive product
Watson Pharmaceuticals, a specialty pharmaceutical company, has received FDA approval of an oral contraceptive product, a low dose oral contraceptive to combine 0.8mg norethindrone and 0.025mg ethinyl estradiol in chewable form, with four 75mg ferrous fumarate, or iron, placebo tablets.
Watson Pharmaceuticals, Inc. and Columbia Laboratories, Inc. today confirmed that, as expected, Watson has received a complete response letter from the FDA for its New Drug Application for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy.