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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.

FDA Steps Into Makena Pricing Dispute In The Name Of "Access"

FDA is citing patient access as the reason behind its unusual decision to insert itself in the middle of a pricing debate involving KV Pharmaceuticals’ pre-term delivery drug Makena.

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