STABILITY: Generic versions of branded products must demonstrate that their products do not deteriorate faster than the branded versions. This usually requires months of testing. As you know, the anti-oxidation of EPA is mitigated via the patented capsule.
That means that GV must invent a new capsule or coating that proves this requirement. Good Luck with that!
Today I want to talk about UNMET NEED & DEMAND:
This is an additional requirement for generic versions of a Branded drug. The indication being sought for generic VASCEPA is hypertriglyceridemia (TG>= 500mg/dl).
This indication does not demonstrate an unmet need nor demand when you consider Lovaza, Generic Lovaza, VASCEPA, Niacin’s, and Fibrates. The market is already saturated for this indication, and the generics will not be economically successful in launching into this crowded field.
Please remind Janet Woodcock of these FDA requirements.
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