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.
- "The efficacy of Fragmin in children was based on a single trial with 38 pediatric patients," the FDA said.
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.
