Covis Statement on FDA Decision to Withdraw Approval of Makena®
Zug, Switzerland, April 7, 2023 – Following the U.S. Food and Drug Administration’s decision, Covis Pharma Group (“Covis”) is effectuating the 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.
The decision from the FDA Commissioner and Chief Scientist deferred to the Center for Drug Evaluation and Research (CDER) to determine next steps to implement the withdrawal. This guidance is available here: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/makena-hydroxyprogesterone-caproate-injection-information.
In furtherance of CDER’s guidance, CDER recognizes that a limited supply of Makena and generics has already been distributed and acknowledges that some healthcare providers might continue to prescribe or administer that limited remaining supply to their patients. The company recommends that healthcare providers consider FDA’s conclusion on the withdrawal of Makena.
As detailed previously, shortly following the 2022 public hearing, Covis requested an orderly wind-down in an effort to voluntarily withdraw Makena. This request included a proposed wind-down period that would allow current patients to complete their course of treatment, rather than face a disruption in care.
The company remains committed to providing patient and provider support services throughout the Makena withdrawal process. Patients who have questions are encouraged to speak with their healthcare providers, or call 1-800-847-3418, Monday–Friday from 8:00 AM–8:00 PM ET. Consultation for healthcare providers is available at 1-877-411-2510, Monday−Friday, 9:00 AM–5:00 PM ET.
Covis Pharma, founded in 2011 and headquartered in Luxembourg, is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at www.covispharma.com.