Drug news
Mallinckrodt files MNK 795 at FDA for Pain
Depomed, Inc. announced that the FDA has accepted for filing a New Drug Application (NDA) from Mallinckrodt for MNK-795.
MNK-795 is a controlled-release oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate to severe Acute Pain where the use of an opioid analgesic is appropriate. MNK-795 is formulated with Depomed's Acuform drug delivery technology. The FDA granted the NDA a priority review.