Trial Profile
Efficacy and tolerability of 17 alpha-hydroxyprogesterone caproate for the prevention of recurrent preterm labour
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 11 Apr 2023
Price :
$35
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At a glance
- Drugs Hydroxyprogesterone (Primary)
- Indications Preterm birth
- Focus Registrational; Therapeutic Use
- Acronyms Meis
- 07 Apr 2023 According to a Covis Pharma media release, following U.S. Food and Drug Administration's decision, company is effectuating withdrawal of Makena (hydroxyprogesterone caproate injection), which has been the only treatment approved to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous preterm birth.
- 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.
- 06 Apr 2023 According to a Food and Drug Administration media release, the U.S. Food and Drug Administration announced the final decision to withdraw approval of Makena to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. The decision was issued jointly by the FDA Commissioner and Chief Scientist. Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce, effective today.