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Elite Pharmaceuticals Inc ELTP
Posted On: 05/07/2013 6:13:22 PM
Post# of 2146
Posted By: Couch


We should get another look on May 10th at how serious the FDA is at mandating whether all  opioids will carry abuse deterrent/resistant technology or not. 


Quote:

Looking ahead, we are waiting for an important FDA ruling on the 10th of May, at which time, the agency is inspected to determine whether the old formulation of  OPANA ER was discontinued for safety reasons. It is our firmly held believe that the best interest of patients, physicians and other stakeholders is served by a strong -- by a show of strong support by FDA for the abuse-deterrent formulation of OPANA ER through the removal of products that rely on non-abuse-deterrent formulations. The  FDA's decision will determine how we compete in the extended-release opioid market, so we are watching and preparing for this news accordingly. We have seen encouraging comments from  FDA supporting the position we have taken on the issue, but we await their decision.

















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