FDA provides further update on Amag Pharma's Makena approval

• AMAG Pharmaceuticals (NASDAQ: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. 5)
• Previously: Covis takes out Amag Pharma for $498M (Oct. 1)
• https://seekingalpha.com/news/3619998-fda-provides-update-on-amag-pharmas-makena-approval