Mallinckrodt announced that the FDA has accepted for filing its New Drug Application (NDA) for MNK-395, referred to as Pennsaid (diclofenac sodium topical solution) 2% w/w in the filing. Pennsaid is a nonsteroidal anti-inflammatory drug (NSAID) being studied in the treatment for pain associated with osteoarthritis of the knee.
Mallinckrodt resubmitted the NDA on August 7, 2013, following a Complete Response Letter issued by the FDA that requested an additional pharmacokinetic study.
Pennsaid 1.5% w/w is already indicated for treatment of signs and symptoms of osteoarthritis of the knee.
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