Remoxy Review Shows How Opana ER Experience Changed US FDA Thinking On New Opioid Formulations
Pain Therapeutics CEO Barbier says comparing Remoxy to Endo's withdrawn Opana ER 'borders on slanderous' and asserts that after three complete response letters, FDA is once again moving goalposts for approval.
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Meeting with US FDA in January will aim to reverse fourth rejection in 10 years; firm still criticizing agency even as it works to reconcile their positions.
Harm Reduction Therapeutics, which has sought funding for a US Rx-to-OTC new drug application, receives grant from Purdue Pharma that enables filing and launching the product in a targeted 100,000 retail locations within two years.