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AMAG Pharmaceuticals Inc.

www.amagpharma.com

Latest From AMAG Pharmaceuticals Inc.

A Year Of Reconsiderations For US FDA Advisory Committees

Correvio’s anti-arrhythmic vernakalant is returning to an advisory committee a dozen years after its first review, continuing a recent pattern of return visits for applications – and 12 years isn’t even close to the longest long back for US FDA panel in 2019.

Advisory Committees Drug Review

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down the surprising US FDA advisory committee endorsement of Twirla and the split decision on whether Makena should be withdrawn.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