Mallinckrodt Pharmaceuticals’ New Drug Application Accepted for Review by FDA ST. LOUIS--(BUSINESS WIRE)--Mallinckrodt (NYSE: MNK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for MNK-395. MNK-395 is 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 ...
Aug. 22, 2013 - Business Wire