Embattled AMAG braces for October FDA Makena adcom, but it need not worry — analyst
When the FDA approved AMAG Pharmaceuticals’ female libido drug, Vyleesi, months ago sans an advisory committee despite weak data — controversy ensued. But the Massachusetts-based drugmaker must now contend with the regulatory fallout of another one of its women’s health drugs: Makena.
Makena — which has been on the market for years as a therapy designed to cut the risk of preterm birth in pregnant women — earlier this year failed a post-confirmatory study. Now, the FDA has set up a meeting of independent advisors in October to figure out whether or not to take it off the shelves.
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