Trial Profile
A Phase 3B, Multi-Center, Randomized, Double-Blind Study of Hydroxyprogesterone Caproate (HPC) Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 05 Jun 2023
Price :
$35
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At a glance
- Drugs Hydroxyprogesterone (Primary)
- Indications Preterm birth
- Focus Registrational; Therapeutic Use
- Acronyms PROLONG
- Sponsors AMAG Pharmaceuticals; Hologic; Lumara Health
- 12 May 2023 According to an European Medicines Agency media release, the French medicines agency (ANSM) requested the PRAC to issue a recommendation on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
- 12 May 2023 According to an European Medicines Agency media release, EMA has started a review of medicines containing hydroxyprogesterone as hydroxyprogesterone caproate is no more effective than placebo in preventing recurrent premature birth or medical complications due to prematurity in the newborn infant. the French medicines agency (ANSM) requested the PRAC to review the risks and benefits of medicines in all their approved uses.
- 07 Apr 2023 According to a Covis Pharma media release the decision from the FDA Commissioner and Chief Scientist deferred to Center for Drug Evaluation and Research (CDER) to determine next steps to implement the withdrawal.This guidance is available on: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/makena-hydroxyprogesterone-caproate-injection-information.