The FDA has given the go-ahead for Pfizer’s blood thinner Fragmin to be used in children. Fragmin isn’t in a new product. It has been available for adults since 1994.
Why this matters: This is yet another example of an older drug getting broader approval with limited testing or evidence on the new target population.
Notable quotes: “The efficacy of Fragmin in children was based on a single trial with 38 pediatric patients.” – FDA
By the numbers: Comparatively speaking, Fragmin is a small medication for Pfizer that brought in $293 million in sales in 2018. This is down from the $382 million it was clearing in 2011. With this new expanded approval, Pfizer now has a bigger population to go after.
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