ST. LOUIS (BUSINESS WIRE) — Mallinckrodt today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for MNK-395. MNK-395 is referred to in the application as PENNSAID ® (diclofenac sodium topical solution) 2% w/w, studied in the treatment of the pain of osteoarthritis of the knee.
The NDA was resubmitted by Mallinckrodt on August 7, 2013, in answer to a Complete Response Letter from the FDA that included the request for an additional pharmacokinetic study.
“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 accepted the application for filing. If approved, this product will be an important addition to the Mallinckrodt Pharmaceuticals product line.”
Mallinckrodt continues to market PENNSAID (diclofenac sodium topical solution) 1.5% w/w, a nonsteroidal anti-inflammatory drug (NSAID) used for the treatment of the signs and symptoms of osteoarthritis of the knee. Under the terms of a U.S. Licensing and Development Agreement with Nuvo Research signed in June 2009, Mallinckrodt is responsible for managing development activities for PENNSAID 2%.