Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


What’s Next For FDA In Face Of Opposing Mifepristone Injunctions

Executive Summary

Agency appeals Texas federal court decision staying its approval of the medication abortion pill. It is unclear how the ruling would be implemented if it stands, and what the impact might be from an opposing same-day order from another court for FDA to keep mifepristone available. Texas ruling could have significant consequences for industry, former FDA attorney says.

You may also be interested in...

Supreme Court Could Curtail Mifepristone Access, Lay Out ‘Road Map’ To Challenge FDA Approvals

Court decision on whether an anti-abortion group has standing to challenge FDA actions could dispose of case or open door to similar suits. Ruling will determine if pre-2016 REMS restrictions are reinstated.

Generic And Branded Mifepristone Remain On US Market Following Supreme Court Stay

GenBioPro will be able to continue selling its generic mifepristone, after the Supreme Court overruled a stay from the Fifth Circuit which could have seen generic approval rescinded and significant restrictions placed on the drug’s use. 

GenBioPro Suit Against FDA May Preserve Generic Mifepristone Approval

GenBioPro has filed a lawsuit against the FDA to try and preserve the approval of its generic mifepristone product, should the Supreme Court allow an order from a Texas judge to overrule the Food and Drug Administration’s approval of the drug.

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts