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Depomed Inc announces Mallinckrodt New Drug Application for MNK-155 accepted for review by FDA

Wednesday, 28 May 2014 08:10am EDT 

Depomed Inc:Says the U. S. Food and Drug Administration (FDA) has accepted for filing a New Drug Application (NDA) from Mallinckrodt (MNK) for MNK-155.Says MNK-155 is an investigational extended-release oral formulation of hydrocodone and acetaminophen that has been studied for the management of moderate to moderately severe acute pain where the use of an opioid analgesic is appropriate.Says MNK-155 is formulated with Depomed's Acuform drug delivery technology.NDA acceptance triggers a $5 million milestone payment to Depomed under a license agreement between Depomed and Mallinckrodt.Says it is also entitled to an additional payment of $10 mln upon approval of the NDA and high single digit royalties on net sales of MNK-155, if approved. 

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