Elite Pharmaceuticals Inc (ELTP)

[dr_lowenstein]

OH, here is what those FDA crooks said recently about a competitor with the same issue as elite:

Sept 10, 2015 FDA comments re Avridi:

• When taken with food
–
Absorption of oxycodone from AVRIDI is substantially delayed.
•
AVRIDI Tmax: Median 4h; Range 1 – 9 h.
•
Roxicodone Tmax: Median 1.5 h; Range 0.5 – 4 h.
–
Oxycodone exposure with AVRIDI is low over 4 – 6 hr compared to Roxicodone
• As demonstrated by substantially lower partial AUC.
–
AVRIDI takes longer to achieve comparable systemic exposurecompared to Roxicodone.
–
Existing IR products do not show delayed Tmax to this extent.

ouch!!!! I would have thought that our A team would have realized they had an issue in Sept, 2015, but.....apparently not