1. Pink Sheet
  2. >>Drug Safety

Medical Organizations Push For Mifeprex Miscarriage Indication, REMS Elimination

 
• By Brenda Sandburg

The American College of Obstetricians and Gynecologists and 48 other groups request the FDA ask Danco Laboratories to file a supplemental NDA for an expanded indication and eliminate requirements for provider and pharmacist certification. For now, Danco is focused on updating the REMS as modified in December.

Mifepristone
Groups advocate for expansion of the mifepristone indication and elimination of its REMS. • Source: Shutterstock

As the Biden administration has fallen short on pledges to increase access to medication abortion, medical organizations are advocating for the US Food and Drug Administration to eliminate restrictions on use of Mifeprex (mifepristone) and expand its indication.

The American College of Obstetricians and Gynecologists submitted a citizen petition to the FDA on behalf of itself and 48 other organizations requesting that the agency ask Danco Laboratories, the holder of the new drug application for Mifeprex, to submit a supplemental NDA adding miscarriage management to the drug's indication

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Drug Safety

More from Pink Sheet