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Wednesday, Sep 18
FDA accepts Epanova NDA, Amarin on watch
- The FDA accepts AstraZeneca's (AZN) NDA for the fish oil-based, hypertriglyceridemia treatment Epanova.
- The product was developed by Omthera, which AZN bought earlier this year to bolster its cardiovascular business in the face of looming patent expiration for Crestor.
- Amarin (AMRN) is on watch, as Epanova competes for the same market as Vascepa.
- See also: The Street debates impact of generic Lovaza (GSK)