Published 1 year ago

Covis Pharma to voluntarily withdraw preterm birth prevention drug from market

Summary by Ground News

Covis Pharma will voluntarily withdraw its preterm birth prevention drug Makena from the market. An FDA advisory committee in October voted to recommend withdrawal due to ineffectiveness. Covis outlined a plan for voluntary withdrawal after the advisory committee hearing to end further proceedings. But the Center for Drug Evaluation and Research did not agree to this proposal.

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Covis Pharma to voluntarily withdraw preterm birth prevention drug from market

Covis Pharma Group has submitted a response to the presiding officer’s report on the FDA advisory committee hearing on the proposal to withdrawal approval for a preterm birth prevention drug, according to a press release.Currently, hydroxyprogesterone caproate injection (Makena, Covis Pharma) is the only FDA-approved treatment to reduce preterm birth risk in pregnant women who have

1 year ago

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