Mallinckrodt announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for PENNSAID(R) (diclofenac sodium topical solution) 2% w/w. PENNSAID 2% is a topical non-steroidal anti-inflammatory drug (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. PENNSAID(R) (diclofenac sodium topical solution) 2% w/w. WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK. Cardiovascular Risk: Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use.

Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. PENNSAID is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. CONTRAINDICATIONS: PENNSAID is also contraindicated in patients: with a known hypersensitivity to diclofenac sodium or any other component of PENNSAID; who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal anaphylactic-like reactions to NSAIDs have been reported in such patients.

WARNINGS AND PRECAUTIONS: Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen. Use with caution in patients with fluid retention or heart failure.

Hypertension can occur with NSAID treatment. Monitor blood pressure closely with PENNSAID treatment. Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury.

Use PENNSAID with caution in patients at great risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE-inhibitors. Anaphylactoid reactions may occur in patients without prior exposure to PENNSAID. NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.

Wash and dry hands before and after use. Avoid contact of PENNSAID with the eyes and mucous membranes; PENNSAID was not evaluated under the conditions of heat application, occlusive dressings overlay, or exercise; therefore, concurrent use of PENNSAID under these conditions is not recommended.