FDA revokes approval of premature birth drug Makena and its generics, citing no clinical benefits in reducing preterm birth risk

Sample article from our Government & Public Policy

April 7, 2023 (press release) –

The Food and Drug Administration today withdrew approval for Makena and its generics, citing a confirmatory study that did not verify clinical benefit. Makena had been approved under the FDA’s accelerated approval pathway to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. Makena and its generics cannot lawfully be distributed in interstate commerce, effective immediately. FDA is aware that some products have already been distributed, so health care providers should talk to their patients, if applicable.

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Dan Rivard
Dan Rivard
- VP Market Development -

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