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# FDA Seeks Makena Drug Withdrawal
- URL: https://www.fdaweb.com/fda-seeks-makena-drug-withdrawal/
- Published: 2020-10-05T12:00:00.000Z
- Updated: 2026-09-14T16:31:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147801

In a rare product approval reversal, FDA has issued a [proposal](https://www.regulations.gov/docket?D=FDA-2020-N-2029&ref=fdaweb.com) to withdraw from the market Amag Pharmaceuticals’ Makena (hydroxyprogesterone caproate injection) from the market because a required postmarket study failed to verify clinical benefit in reducing the risk of preterm birth in women who previously had a spontaneous (unexplained) preterm birth. Makena was granted [accelerated approval](https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval?ref=fdaweb.com), which required the company to conduct a clinical trial to confirm the drug provided clinical benefit to newborns.

“The required confirmatory trial failed to show that Makena is effective for improving the health of babies born to women with a history of unexplained preterm birth,” an [FDA notice ](https://u7061146.ct.sendgrid.net/ls/click?upn=4tNED-2FM8iDZJQyQ53jATUURzbOiTj4rjf8eQ-2FYEfOQ5THSul0bFGo4FhyR4b-2BPkN6tXfIb03jEQfD9nEWL3f9wgMAtjLAQrGivegWKtTaBdi73g83EDm7rf5ZEqUt9SYJyzPPGDOjsmR46CptDfKppSGRCSjzkpL9I07maP8OWrKYE6m-2F7kZtay4huqAfmZAVJXecGmA0QoLMvX9W93Xe93NNWOdYu5aCMC-2Bogc1HIyF0qZuQix90KPE3SCKzE9tyNv1xruAYWUc-2FPRL0FxlVrOh78qRjkBXhzDHsj-2Fa8x9ESMkrC-2FlTRrPT4ZVPeVB2monUlKsYbaYIUBZUFy14BHE-2FZdPSn4CMmPaTzOiojgAoBE9VrUOc3nU1XN3YwYkG0T4PN-2BfvX1n1LSqfjkyAx81ydteH5sN4aiWIYbCwQYt2DSJhbXbAQppG3GrVj-2BRnQ1EdsKrHqDhKqY5psokpGLY268C-2BAM9kkpxKmspVvwOBFQuqaN8oWNuQTRJCmycuG4gqSVrc0waQdpp7Yj98cmltPe3mMbNru2PXLD31DlI-3DAN8U%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLIZH-2BlHUpIN1Fpx16wXLzBItZQB-2B865N-2BRM-2FfR3UV9b-2B3x5yDeI-2BTg-2FGBCQMWf44N-2BxzyDcnK1fkynjeStZWmt-2F5GMD-2FqISD-2FQs4flVrRq0HpVQdUKkHDM4sPaYbahv-2FFKHRDZJ-2B-2FEDePnQfRYxcij5YHkxodHbaQefdqsSEC5wTdeHhw8vSjwtXcEi-2BIs3Dx7kjbUZcamm6J041Hxo0l2FA1v26DkM4SrEYLzU-2Fg-2FGnbAZ84MArhliWbK3kYdCzoXHKF2MtMchUIbcKdIYLG55vyHzMRcsJRCtwpR1bKqut-2BKOBWcboVf2OLj0yubMu-2FA-3D&ref=fdaweb.com)says. “We also determined that the available evidence does not show that Makena reduces the risk of preterm birth. Therefore, CDER has proposed that Makena be withdrawn from the market and has issued a notice of opportunity for a hearing (NOOH) to the application holder of Makena, Amag Pharmaceuticals. FDA also sent the NOOH to the application holders for the approved generics to Makena for an opportunity to comment.”