Makena Withdrawal Brings End to Drug at Times Mired in Controversy

The FDA will withdraw Makena (hydroxyprogesterone caproate) from the U.S. market, the agency said April 6. The move follows manufacturer Covis Pharma Group saying on March 7 that it had requested an “orderly wind-down” of the drug from the market. However, “effective today, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce,” said the agency in its statement. “Approvals of these drugs have been withdrawn because the drugs are no longer shown to be effective and the benefits do not outweigh the risks for the indication for which they were approved.”

The decision brings to a close a long-running saga that started more than a decade ago, as well as shines a spotlight on the FDA’s often-criticized accelerated approval pathway.

© 2024 MMIT
Angela Maas

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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