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FDA Clears 31 New Molecular Entities In 2004, Up 10 From Previous Year

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

NME rebound in 2004? Final count is 31 versus 21 in 2003 – however, 2004 tally includes several atypical new molecular entities. Top 10 pharma companies hold small share of the total, with no companies clearing more than two NMEs during the year. Over 20% of the approvals came in the last two weeks of December

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Omacor indication limited to severe hypertriglyceridemia because of increased LDL-cholesterol associated with the drug, FDA review documents indicate. Ross was unable to support cardioprotective benefit or reduction of risk of pancreatitis; omega-3 fatty acids, also marketed in U.S. as a dietary supplement, is approved for cardiovascular outcomes in other countries

Omacor Potential To Increase LDL Cholesterol Limits Use To Severe Patients

Omacor indication limited to severe hypertriglyceridemia because of increased LDL-cholesterol associated with the drug, FDA review documents indicate. Ross was unable to support cardioprotective benefit or reduction of risk of pancreatitis; omega-3 fatty acids, also marketed in U.S. as a dietary supplement, is approved for cardiovascular outcomes in other countries

Year-End 2004 Submissions Slow; FDA Returns To Boom In Approvals

Year-end submissions are down, but end-of-year approvals are up at 15 versus six in 2003. December 2004 saw 14 filings compared to 17 a year ago. Submission slow-down reflects diminishing late-stage pipelines across industry; only five of the end-of-year filings were for new molecular entities

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