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Mallinckrodt files MNK 795 at FDA for Pain

Read time: 1 mins
Last updated: 30th Jul 2013
Published: 30th Jul 2013
Source: Pharmawand

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.

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