FDA rejects Abbott’s application for extended-release Vicodin

ABBOTT PARK, Ill. The Food and Drug Administration has rejected Abbott Labs’ application for an extended-release of Vicodin, Abbott said Monday.

Abbott said it had received a complete response letter, which indicates that the FDA has found deficiencies that prevent it from approving a drug.

The company is seeking approval for the drug, known generically as hydrocodone with acetaminophen. It originally applied for approval in 2007.