Accelerated Approval: US FDA, Covis Navigate Novel Issues With Makena’s Withdrawal

Ahead of the final withdrawal decision, FDA terminated internal separation of functions so that the Office of the Commissioner and CDER could coordinate next steps; Makena’s NDA approval has been withdrawn, but the product’s website lives on, albeit with a pop-up window explaining the regulatory action.

Makena popup
A pop-up about FDA's withdrawal order greets visitors to the Makena.com product website. • Source: Makena

The US Food and Drug Administration and Covis Pharma are navigating uncharted waters with the agency-ordered withdrawal of preterm birth prevention drug Makena (hydroxyprogesterone caproate) for lack of demonstrated efficacy.

Makena’s label carried only one indication – to reduce the risk of preterm birth in women with a singleton pregnancy...

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

More from Post-Marketing Regulation & Studies

CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By 

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

More from Product Reviews

CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.