BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 7.09.2022

Proposal To Withdraw Approval of MAKENA; Hearing; Correction

The Food and Drug Administration (FDA) is correcting a notice entitled "Proposal To Withdraw Approval of MAKENA; Hearing" that appeared in the Federal Register of August 17, 2022. The document announced the hearing on the Center for Drug Evaluation and Research's proposal to withdraw approval of MAKENA (hydroxyprogesterone caproate injection, 250 milligrams per milliliter, once weekly), new drug application 021945, held by Covis Pharma Group/Covis Pharma GmbH. The document was published with an incorrect deadline. This document corrects that error.

Source: Federal Register — Food and Drug AdministrationOpen original release →