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Preterm Birth Drug Withdrawn After 12 Years

Covis Pharma Group Drugs (Pharmaceuticals) Food and Drug Administration Pregnancy and Childbirth Premature Babies Recalls and Bans of Products

Preterm Birth Drug Withdrawn After 12 Years

The F.D.A. seemed poised to rescind approval of Makena, after studies over time indicated the treatment did not halt early childbirth for many women.

By Christina Jewett

FDA Panel Recommends Pulling Preterm Birth Drug From the Market

Drugs (Pharmaceuticals) Food and Drug Administration Pregnancy and Childbirth Premature Babies Regulation and Deregulation of Industry

FDA Panel Recommends Pulling Preterm Birth Drug From the Market

The agency has weighed years of study that showed the treatment given accelerated approval 11 years ago was not effective.

By Christina Jewett