NCE: My guess is that FDA is trying to make more general/detailed guidance on this matter. GILD's Stribild which is a fixed dose combination of 4 drugs, 3 of which previously approved, 1 never before still hasn't get exclusivity period decided yet since approval last August, similar to AMRN's Vascepa. GILD is petitioning FDA for 5-year exclusivity. Per previous guidance's strict interpretation, it should not. While I don't expect Vascepa getting NCE, had been my expectation since I first looked at this matter one year ago, it does raise some valid questions, as in GILD's case. FDA could be trying to give more detailed guidance on this subject matter under difference situations.
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