Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

FDA confirms Egalet's story.


http://www.medpagetoday.com/neurology/generalneurology/62441

An FDA spokesperson told MedPage Today that MorphaBond, another morphine product, has "marketing exclusivity for labeling describing the expected reduction of abuse of single-entity, extended-release morphine by the intranasal route due to physicochemical properties."

Notice the length and specificity of the quote to MedPage from an official FDA source. When EGLT said on their CC that they didn't get nasal ADF Label because MorphaBond has market exclusivity, I was skeptical. (I know, right, so unlike me.) But there it is, officially confirmed. So I guess that means they will get the label in 2018 when MorphaBond market exclusivity runs out? Really good for EGLT if so. I had no idea the ADF Label is considered part of FDA exclusivity. Seems kinda dumb.