Amarin lashes out at FDA with lawsuit over Vascepa exclusivity

Amarin ($AMRN), which has faced a series of setbacks getting its fish oil pill to market, is lashing out at the FDA for some of its problems, Bloomberg reports. The Irish drugmaker is suing the agency for not giving its pill 5 years of exclusivity, instead only approving it for three years. At issue is whether the active ingredient in Vascepa, icosapent ethyl, deserves additional protection, since it also is present in GlaxoSmithKline's ($GSK) Lovaza, another Omega 3 pill. Amarin claims Vascepa's ingredient is different enough to deserve the additional two years of protection, Bloomberg reports. Amarin's Vascepa was approved last year to treat patients with very high triglycerides in their blood--levels of 500 mg per deciliter and above--but in October it was denied a much broader use that would have made it a potentially more valuable product. The exclusivity issue also has hung over Vascepa, dampening interest that other drugmakers might have on partnering with Amarin. Story | More

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