Endo Pharma withdraws its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for Opana ER.
Endo International plc announced that based on an August 11, 2016 discussion with the FDA, the Company has decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for Opana ER without prejudice to re-filing. The Company plans to continue collecting and analyzing epidemiological data relating to Opana ER. Endo's financial projections for 2016 did not assume approval of the sNDA.
The sNDA for Opana ER, which is formulated using INTAC Technology, included studies designed to evaluate the abuse deterrence of the formulation. INTAC Technology increases tablet hardness using a high molecular weight polymer (polyethylene oxide).
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
3 mins