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FDA user fee date for King's Embeda passes without action

This article was originally published in Scrip

Executive Summary

The US FDA's review ofKing Pharmaceuticals' (formerly Alpharma's) Embeda, a modified-released formulation of morphine coupled with the opioid antagonist naltrexone, has been extended beyond the late December user fee date. "Our discussions with the FDA continue to progress, and we remain confident in the strength of our regulatory submission," King chief science officer Eric Carter said. In November an FDA advisory panel said Embeda provided an incremental improvement over existing controlled-release morphine products because it appeared to be less susceptible to abuse and misuse (Scrip Online, November 17th, 2008). However, the panel called for more data on potential abuse through intravenous injection, snorting and chewing, and a risk evaluation and mitigation strategy (REMS) is needed for approval. King gained Embeda through its recent acquisition of Alpharma.

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