ARTICLE | Regulation
Makena returning to spotlight as FDA allows hearing
Preterm birth drug has long been focus of drug pricing, efficacy concerns
August 23, 2021 8:06 PM UTC
Makena will return to center stage of a turbulent, decade-long drug pricing saga when FDA holds a public hearing to discuss the Covis-owned drug and its generic equivalents to reduce preterm birth.
Covis Pharma S.a.r.l. requested the hearing in October after the agency proposed to withdraw approval of Makena and other forms of hydroxyprogesterone. ...
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