NeLM news service
FDA Committee does not recommend approval of progesterone vaginal gel 8% for the reduction of risk of preterm birth

Source: BioSpace

Date published: 24/01/2012 16:53

Summary
by: Nicola Pocock

According to BioSpace, the US FDA’s Advisory Committee for Reproductive Health Drugs does not recommend approval of progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length at the mid-trimester of pregnancy. While panel members generally agreed that the product is safe, they stated that more information is needed to support approval.

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