FDA approves 2% Pennsaid for Osteoarthritis Pain-Mallinckrodt
The FDA has approved Mallinckrodt's New Drug Application for Pennsaid (diclofenac sodium topical solution) 2% w/w for Pain of Osteoarthritis. Pennsaid 2% is a follow-on product to original 1.5% w/w solution which has been marketed by Mallinckrodt in the US since 2010. Pennsaid 2% will be the first twice per day dosed topical NSAID available in the US for the treatment of the Pain of Osteoarthritis of the knee.
The most common adverse events in a Phase II clinical trial of PENNSAID were application site reactions, such as dryness (22%), exfoliation (7%), erythema (4%), pruritus (2%), pain (2%), induration (2%), rash (2%), and scabbing (1%). Nuvo has licensed the US sales and marketing rights for both Pennsaid 1.5% and 2% to Mallinckrodt.
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