Drug news
FDA does not accept NDA for Crinone gel (Watson) for use in reducing risk of Preterm Birth
The FDA has issued a complete response to an NDA for Crinone (progesterone vaginal gel 8%), from Watson, 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. The letter stated that the effect of treatment with Crinone in reducing the risk of Preterm Birth in women with a short uterine cervical length at