1. Pink Sheet
  2. >>Product Reviews
  3. >>Post-Marketing Regulation & Studies

Makena: Professional Societies Finally See Eye To Eye With US FDA’s Drugs Center

 
• By Sue Sutter

After two decades of recommending use of intramuscular 17-OHPC to prevent preterm birth, the American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine revised their clinical guidelines in the wake of the FDA’s order withdrawing Covis’ Makena and its generics.

Change in direction
ACOG and SMFM altered their clinical recommendations on Makena only after the FDA's withdrawal order came down. • Source: Shutterstock

For the first time in years, the US FDA’s Center for Drug Evaluation and Research and two professional societies are publicly aligned on the utility of Covis Pharma’s Makena (hydroxyprogesterone caproate) and its generics for prevention of preterm birth.

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 Post-Marketing Regulation & Studies

Global Regulators Consider Extending Pilot On Post-Approval CMC Changes After Positive Findings

 
• By Eliza Slawther

Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.

Pharma Industry Wants Easier Access To England’s Revamped NHS Data Sharing System

 
• By Eliza Slawther

The pharmaceutical industry was not sufficiently involved in designing updates to England’s health data infrastructure, leading to a “misalignment” between company needs and what is currently being delivered, according to the results of a survey by the Association of the British Pharmaceutical Industry.

US FDA In ‘First Stages’ Of Reconsidering Black Box For Antipsychotics

 
• By Ramsey Baghdadi

Patient advocates and sponsors want the US to reconsider a 20-year-old class warning against the use of antipsychotics in patients with dementia. The agency is weighing the issue, but also defending the current labels of newer agents.

Shorter Gene Therapy Postmarket Studies ‘On The Table’

 
• By Derrick Gingery

Amid complaints about the challenges of following gene therapy patients for up to 15 years, OTP Director Nicole Verdun said the FDA is considering how to conduct long-term postmarket studies more efficiently.

More from Product Reviews

Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 
• By Neena Brizmohun

The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
• By Bridget Silverman

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.