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FDA Clears Forest’s Savella, The First Fibromyalgia-Only Drug

This article was originally published in The Pink Sheet Daily

Executive Summary

The selective serotonin and norepenephrine reuptake inhibitor will require a MedGuide, and thus a REMS.

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Forest’s Fetzima Will Test Enantiomer Exclusivity Policy Change

The antidepressant levomilnacipran, an enantiomer of Forest’s fibromyalgia drug Savella (milnacipran), could be the first product to take advantage of an FDA Amendments Act provision that allows enantiomers of previously approved drugs to qualify for five years of new chemical entity exclusivity.

FDA’s Rollover Reviews: Missed Deadlines Could Inflate 2009 Approval Tally

FDA is heading into 2009 with at least a dozen missed review deadlines held over from 2008 - potentially setting up the agency and industry for what could be an unusually higher number of drug and biologic approvals this year

FDA’s Rollover Reviews: Missed Deadlines Could Inflate 2009 Approval Tally

FDA is heading into 2009 with at least a dozen missed review deadlines held over from 2008 - potentially setting up the agency and industry for what could be an unusually higher number of drug and biologic approvals this year

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