FDA keeps door open to cheap versions of KV's Makena

The battle over KV Pharmaceuticals' ($KV.A) pricey preterm-labor drug, Makena, with pharmacy compounders who can make it for next to nothing has hit a new phase. The FDA this week announced it found no major safety problems with compounded versions of Makena. Then KV released a statement emphasizing another part of the FDA's announcement--that agency-approved drugs provide greater assurance of safety and efficacy. After getting approval for its drug, KV began charging $1,500 a dose, while previously women were able to buy it for about $20 a dose from compounders. In the outcry, KV lowered the price to $690 but the FDA allowed the compounded versions to remain on the market. Then KV asked the FDA to investigate whether they were safe and consistent. The FDA this week said it found that all of the APIs met standards for potency and total purity. When compared with Makena's NDA standards, a few of the samples fell short on some measures. And so the fight continues. Story | More

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