US FDA accepts Pennsaid 2% NDA for review

22 August 2013

The US Food and Drug Administration has accepted for filing US drugmaker Mallinckrodt’s (NYSE: MNK) New Drug Application for MNK-395, referred to in the application as Pennsaid (diclofenac sodium topical solution) 2% w/w, studied in the treatment of the pain of osteoarthritis of the knee.

The NDA was resubmitted by Mallinckrodt on August 7, in answer to a Complete Response Letter issued by the FDA in March that included the request for an additional pharmacokinetic study. The FDA has indicated to Mallinckrodt that it expects to respond to the NDA by February 7, 2014.

“We have a diverse portfolio focused on pain management, and are committed to providing options for patients who suffer from osteoarthritis of the knee,” said Mark Trudeau, chief executive and president of Mallinckrodt. “We are pleased that the FDA accepted the application for filing. If approved, this product will be an important addition to the Mallinckrodt Pharmaceuticals product line,” he added.

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