Columbia sinks on FDA rejection of Watson preterm birth drug
This article was originally published in Scrip
The US FDA took the advice of its outside advisers and rejected Watson Pharmaceuticals' and Columbia Laboratories' new drug application (NDA) for a progesterone vaginal gel 8% as a therapy to reduce the risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy – declaring that more clinical work was needed before the medicine could enter the US market.
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