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K-V Gets FDA To Test Adequacy Of Makena’s Competing Compounded Products

This article was originally published in The Pink Sheet Daily

Executive Summary

Compounded hydroxyprogesterone caproate and their APIs show they vary in potency and purity, K-V Pharmaceutical says; FDA is conducting its own analysis.

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Regulatory News, In Brief

CDC panel recommends combined regimen of Pfizer’s Prevnar 13 and Merck’s Pneumovax 23 in immunocompromised adults; FDA issues “complete response” letters and completes review of compounded hydroxyprogesterone.

Columbia’s Progesterone Faces FDA Skepticism Over Foreign Data At Advisory Committee

The agency rejects the sponsor’s statistical analysis and says there is no statistically significant evidence of efficacy in the U.S. population, and the product seems likely to face a request for another trial from the advisory panel.

KV Cuts Makena Price 54%, Increases Medicaid Rebates, But Is It Enough?

Bowing to public pressure and following an unusual intervention by FDA, KV Pharmaceuticals announced April 1 it has cut the list price of its new preterm birth prevention drug Makena (hydroxyprogesterone caproate) by 54% – from $1,500 to $690 per injection – effective immediately.

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