Watson receives complete response letter from FDA for progesterone vaginal gel 8%
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.
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.