FDA withdraws approval for premature birth drug

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.
Related News Articles
Headline
The Food and Drug Administration has issued early alerts for certain Spectrum infusion pumps from Baxter and Abiomed Automated Impella Controllers. The agency…
Headline
The latest video in the AHA’s series “Medicaid: Real Lives, Real Care” features Melissa Fannon-Wisner, DNP, nurse educator and nurse practitioner at Valley…
Headline
Kevin McEwan, DNP, R.N., chief nursing officer at Madison Memorial Hospital, shares how Medicaid provides vital behavioral health and maternal and child care…
Headline
The Food and Drug Administration has approved a new, first-of-its-kind semiannual HIV prevention medication, Gilead Sciences announced June 18. The company…
Headline
The Alliance for Innovation on Maternal Health, with support from the Health Resources and Services Administration, will host a five-part learning series…
Blog
Even before the COVID pandemic, the mental health and wellness of our young people was failing. The pandemic exacerbated the crisis and made it difficult for…