BioCentury
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. ...

Get Unlimited Access
Continue reading with a free trial.
Or Purchase This Article

BCIQ Company Profiles

Covis Group S.a.r.l.