FDA approves New Drug Application for PENNSA 2%

Mallinckrodt (NYSE: MNK) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for PENNSAID^® (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).

"We have a diverse portfolio focused on pain management, and are committed to providing options for patients who suffer from osteoarthritis of the knee," said Mark Trudeau, Chief Executive Officer and President, 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."

U.S. sales and marketing rights for PENNSAID 2% are licensed to Mallinckrodt by Nuvo Research Inc.