Makena Hearing involving the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee - Day 2 |
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The Food and Drug Administration (FDA) has granted a hearing on the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena (hydroxyprogesterone caproate injection, 250 milligrams (mg) per milliliter (mL), once weekly), new drug application (NDA) 021945, held by Covis Pharma Group/Covis Pharma GmbH (Covis). This notice provides information and details regarding the hearing, including the time, date, and format of the hearing, as well as the questions to be posed to the advisory committee at the hearing.
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