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AMAG Pharmaceuticals Inc.

www.amagpharma.com

Latest From AMAG Pharmaceuticals Inc.

US FDA Tried, But Failed, To Take Compounding Issue Off The Table At Makena AdComm

Clinicians and patients would look for 17P wherever they could find it if AMAG’s FDA-approved formulation of the preterm birth drug comes off the market, panelists said; Cowen analysts believe the potential for safety concerns posed by compounded formulations will save Makena from the regulatory chopping block.

Advisory Committees Post Market Regulation & Studies

AMAG Open To Another Makena Trial, But Also Appears Ready To Challenge Any Withdrawal Request

CEO William Heiden reaffirms commitment to preterm birth drug and suggests AMAG would seek a hearing under the accelerated approval regulations if the US FDA were to request withdrawal; another placebo-controlled confirmatory trial may be possible in European and South American countries, company says.

Advisory Committees Post Market Regulation & Studies

Pink Sheet Podcast: Twirla Adcom Surprise And Makena Adcom Questions

Pink Sheet reporters break down the surprising US FDA advisory committee endorsement of Twirla and the split decision on whether Makena should be withdrawn.

Advisory Committees FDA

AMAG’s Makena: Did Accelerated Approval Kill The Confirmatory Trial?

Sponsor’s assertion that recruitment of high-risk, US patients was negatively impacted by the preterm birth drug’s availability under accelerated approval led some advisory committee members to opine that Makena came to market too soon; the experience could make the FDA more cautious about granting accelerated approval unless confirmatory studies are at an advanced stage.

Advisory Committees Post Market Regulation & Studies
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