AMAG - FDA provides further update on Amag Pharma's Makena approval

AMAG Pharmaceuticals (AMAG) has received FDA notification that the Agency is proposing to withdraw approval of Makena (hydroxyprogesterone caproate injection), a treatment approved to reduce preterm birth in pregnant women who have had a prior spontaneous preterm birth.The FDA also notified that the company has the opportunity to request a hearing on the withdrawal. AMAG is evaluating its full range of potential options. The company has 15 days to respond, indicating whether it would like to proceed with a hearing.If AMAG does request a hearing, the FDA Commissioner would decide whether to grant AMAG’s request and, if granted, would conduct a hearing and decide whether to withdraw approval following the hearing.This process can take months and during this time Makena and the approved generics will remain on the market.The company expects the Covis transaction to close in November 2020.Previously: FDA to yank approval for Amag Pharma's Makena; shares down 6% (Oct.

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FDA provides further update on Amag Pharma's Makena approval