Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Endo has controversial product, also.

Another ER product with an AdCom meeting and the FDA has discussed problems with ER products.

They are applying for ADF label when the product is not only well known to have rampant IV abuse but also the ADF formula is specifically implicated in terrible consequences of IV abuse, such as HIV and Hep C outbreaks, clotting disorders, and endocarditis. Opana ADF has been a total nightmare for Endo. I cannot believe they are even applying for a label change. The more likely outcome of this AdComm will be product removal instead of labeling upgrade.