Watch out, GlaxoSmithKline--and Amarin. Teva Pharmaceutical Industries has launched its generic version of Glaxo's fish-oil pill, Lovaza, designed to lower triglyceride levels in patients with cardiovascular disease.
It hasn't been easy being Amarin over the last several months. The Irish drugmaker slammed into one obstacle after another. Read more from FiercePharmaMarketing >>
After a rough go with the FDA sent its shares spiraling downward, Amarin has at last found a partner to help commercialize its fish-oil-derived pill for high triglycerides.
It hasn't been easy being Amarin over the last several months. The Irish drugmaker slammed into one obstacle after another. New chemical entity status for the key ingredient in its cardiovascular drug Vascepa? No, says the FDA. Permission to market the drug to vast numbers of new patients? No again.
Amarin's lawyers were just in court last week suing the FDA for limiting the exclusivity it granted the drugmaker's fish oil pill Vascepa. But the Irish drugmaker hustled them back to court Tuesday, this time to sue AzstraZeneca, which is awaiting FDA approval on its own product for treating super-high cholesterol.
Amarin, 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.
For Amarin, FDA approval for its drug Vascepa wasn't enough. The company needed more from the agency. For one thing, it needed the FDA to deem Vascepa, a cardiovascular drug derived from fish oil, a New Chemical Entity. That designation comes with 5 years of market exclusivity. Amarin didn't get it.
Amarin's hopes of expanding the label for its omega-3 pill look even bleaker as the FDA has denied the company's appeal to reconsider its clinical data, sending shares down another 25% in premarket trading Tuesday.
Amarin's regulatory fortunes haven't improved in the new year, as the FDA has again put off a decision on the company's fish oil pill for high cholesterol, indefinitely postponing a final approval on the troubled drug.
Amarin will have to wait until the new year to find out whether it's fish oil pill Vascepa will be approved for a wider indication.