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FDA withdraws only premature birth drugs from market

FDA withdraws only premature birth drugs from market



On Thursday, the U.S. Food and Drug Administration announced its final decision to withdraw approval for Makena, a drug approved more than a decade ago to reduce the risk of premature birth. , states that the benefits of taking do not outweigh the risks.

“It is tragic that scientific research and the medical community have yet to discover treatments that have been shown to be effective in preventing premature birth and improving neonatal outcomes for black women.” FDA Commissioner Dr. Robert Calif said in a statement. “But fundamentally, the touchstone of FDA drug approval is a favorable benefit her risk assessment. Without that favorable assessment, the drug should not have FDA-approved status.”

Effective Thursday, the agency said Makena and its generics are no longer approved and cannot be legally distributed in interstate commerce.

Last month, the drug’s makers said they were moving to withdraw the drug from the market after an FDA panel said it was ineffective.

“While we support Makena’s favorable risk-benefit profile, including efficacy for women at highest risk of preterm birth, we are voluntarily withdrawing the product and working with the FDA to seek to achieve an orderly phase-down. ” said Chief Innovation Cobis Pharma. His officer, Dr. Raghav Chari, said in a news release at the time:

In October, the FDA’s Obstetrics, Reproductive and Urology Drugs Advisory Committee voted that Makena should not remain on the market because large studies have not shown efficacy. It also voted that post-market trials have shown no benefit to babies, and no evidence that Makena reduces the risk of premature birth in women who have experienced premature birth.

Covis said it outlined a withdrawal plan shortly after the committee hearing, including a phased relaxation period that would allow patients to complete a 21-week course of treatment. However, the FDA’s Center for Drug Evaluation and Research rejected the plan.

The FDA said that while the approval for Makena and its generic drug was revoked, the FDA is aware there is already a supply of the product in circulation.Patients with questions should consult their healthcare providers said there is a need.




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