Mallinckrodt has received approval from the Food and Drug Administration for its New Drug Application (NDA) for Pennsaid 2% (weight/weight), a topical pain medication for knee osteoarthritis.


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Mallinckrodt gains approval for osteoarthritis pain solution

January 17th, 2014

ST. LOUIS – Mallinckrodt has received approval from the Food and Drug Administration for its New Drug Application (NDA) for Pennsaid 2% (weight/weight), a topical pain medication for knee osteoarthritis.

The company said Friday that Pennsaid 2% (diclofenac sodium topical solution) comes in a user-friendly metered dose pump bottle, providing 20 mg per pump, and is applied twice daily directly to the affected knees.

U.S. sales and marketing rights for Pennsaid 2%, a nonsteroidal anti-inflammatory drug (NSAID), are licensed to Mallinckrodt by Nuvo Research Inc.

"We have a diverse portfolio focused on pain management and are committed to providing options for patients who suffer from osteoarthritis of the knee," stated Mark Trudeau, president and chief executive officer of Mallinckrodt. “We are pleased that the FDA approved the application and believe this product will be an important addition to the Mallinckrodt Pharmaceuticals' product line."

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