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Forest’s Fetzima Will Test Enantiomer Exclusivity Policy Change

 
• By Sue Sutter

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.

Forest Laboratories Inc.’s antidepressant Fetzima (levomilnacipran) appears positioned to be the first beneficiary of a 2007 law changing how FDA awards exclusivity for drugs that are enantiomers of previously approved products.

FDA approved Fetzima, a serotonin and norepinephrine reuptake inhibitor (SNRI), for treatment of major depressive disorder July 25

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