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Single-dose Makena not approved by FDA
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The FDA has issued a complete response letter to AMAG Pharmaceuticals indicating that single-dose Makena (hydroxyprogesterone caproate injection), cannot be approved in its current state.
The progesterone drug reduces the risk of preterm birth in singleton pregnancies among women who have spontaneously delivered preterm in the past, according to the release.
Makena is already approved by the FDA in a multidose form that consists of five weekly injections.
AMAG is working with its manufacturer to submit a reply to the FDA with the additional information that was requested in the response letter.
“While we are disappointed by this delay, we believe the single-dose, preservative-free vial is an important step in our next generation development program for Makena, and we remain committed working with the FDA to bring this product to market. Improving the healthcare provider and patient experience with Makena through the development of customer-friendly line extensions is a key priority for the company” William Heiden, CEO of AMAG, said in a press release.