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Acura Pharmaceuticals Announces Paragraph IV ANDA Filing for OXECTA(R)


Acura Pharmaceuticals(NASDAQ: ACUR), a specialty pharmaceutical company developing products intended to address medication abuse and misuse, today announced that it has received notification from a generic sponsor of the filing of an Abbreviated New Drug Application (ANDA) for a generic drug listing Pfizer Inc.'s OXECTA (oxycodone HCl) Tablets CII as the reference listed drug. OXECTA is covered by U.S. patents issued to Acura and licensed to Pfizer. The notification includes a Paragraph IV certification indicating the generic sponsor believes Acura's patents are invalid, unenforceable or not infringed. Acura intends to take appropriate action to enforce its intellectual property.

Posted-In: News FDA


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