Mallinckrodt Says FDA Approves NDA For Pennsaid 2% - Quick Facts

(RTTNews) - Mallinckrodt (MNK) announced Friday that the U.S. Food and Drug Administration or FDA has approved the New Drug Application or NDA for Pennsaid (diclofenac sodium topical solution) 2% w/w. Pennsaid 2% is a topical non-steroidal anti-inflammatory drug or NSAID approved for use in the treatment of the pain of osteoarthritis of the knee(s).

Pennsaid 2% is supplied in an easy to use metered dose pump bottle and is applied twice each day. Pennsaid 2% delivers an accurate amount (20 mg of diclofenac per pump actuation) and can be applied directly to the affected knee(s).

U.S. sales and marketing rights for Pennsaid 2% are licensed to Mallinckrodt by Nuvo Research Inc. (NRI.TO).

Mallinckrodt advised that Pennsaid should not be used in pregnant or lactating women and is not approved for use in pediatric patients.

Nuvo Research said that Mallinckrodt will Launch Pennsaid 2% in the U.S. in the first-quarter of 2014.

Nuvo Research noted that Pennsaid 2% is a follow-on product to original Pennsaid (diclofenac sodium topical solution) 1.5% w/w (Pennsaid 1.5%) which has been marketed by Mallinckrodt in the U.S. since 2010. Pennsaid 2% will be the first twice per day dosed topical NSAID available in the U.S. for the treatment of the pain of osteoarthritis of the knee. Nuvo has licensed the U.S. sales and marketing rights for both Pennsaid 1.5% and Pennsaid 2% to Mallinckrodt.