May 20, 2019

A new approval for an old blood thinner

The FDA gave the OK last week for Pfizer's blood thinner Fragmin to be used in children — but Fragmin is not new, it's been on the market for adults since 1994.

Why it matters: This is another case of an older drug getting broader approval with limited evidence.

Between the lines: Fragmin is a relatively small medication for Pfizer, generating $293 million in sales in 2018, down from when sales were about $382 million in 2011. But getting an expanded approval will immediately create a return for Pfizer because the drug is still the same product — now with a bigger population to treat.

Go deeper: "Almost half of all new drug approvals in 2018 relied on one clinical trial," Zachary Brennan of RAPS Regulatory Focus reports.

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