Astrazeneca ($azn) has won fda approval for its new prescription-strength fish oil therapy for artery-clogging fats, but don't look for it to help much in its nascent effort to convince investors that its bright prospects should make them steer clear of pfizer's ($pfe) takeover pitch. this drug is headed into a crowded field that now includes a low-priced generic competitor.

      Astrazeneca's plan all along has been to get this drug and market it as a combo with crestor, its $6.2 billion megablockbuster which loses patent protection in 2016. crestor, meanwhile, has been steadily losing market share to generic copies of lipitor.

      Astrazeneca executed a $443 million deal a year ago--$323 million in cash along with up to $120 million in contingent value rights--to acquire princeton, nj-basedomthera, which developed epanova. for astrazeneca it was a shortcut to regulatory agencies, offering up a near-term product prospect for severe hypertriglyceridemia.

      At least one analyst pegged potential annual sales at $1 billion, but thomson reuters' average projection among analysts was a far more modest $322 million. still, any success is likely to be welcome at astrazeneca as it tries to struggle free from pfizer's $106 billion takeover offer.

the once-daily omega-3 therapy demonstrated its ability to lower triglycerides and non-hdl cholesterol from baseline after 6 months of treatment over the course of a phase iii study. omthera will be poised to take on glaxosmithkline's ($gsk) lovaza as well as vascepa, which amarin ($amrn) has been struggling to launch. troubles with vascepa have created a cloud over epanova's future, which has been further blighted by teva's ($teva) recent announcement that it is now ready to launch the first generic of lovaza in the u.s."this approval is a significant milestone for astrazeneca, as it strengthens our existing portfolio of cardiovascular medicines," says briggs morrison, one of three r&d chiefs at astrazeneca. "we are committed to further assessing the clinical profile of epanova and to identifying other patient groups it may benefit."

      Omthera obtained epanova under a license from swizterland's chrysalis pharma.