Nuvo: FDA accepts to review New Drug Application for PENNSAID 2%

Aug 22 2013

Nuvo Research Inc. (Nuvo) (TSX:NRI), a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and the development of its immune modulating drug candidate WF10 today announced that its U.S. licensee for PENNSAID^® (diclofenac sodium topical solution) 1.5% w/w and PENNSAID 2% (diclofenac sodium topical solution) 2% w/w, Mallinckrodt (NYSE: MNK) has advised that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the New Drug Application (NDA) for PENNSAID 2% submitted by Mallinckrodt on August 7, 2013. The FDA has indicated to Mallinckrodt that it expects to respond to the NDA by February 7, 2014.

On March 4, 2013, Mallinckrodt received a Complete Response Letter (CRL) from the FDA following the review of Mallinckrodt's New Drug Application for PENNSAID 2%.   In the CRL, the FDA required that Mallinckrodt complete a pharmacokinetic (PK) study comparing PENNSAID 2% to original PENNSAID. Mallinckrodt completed the PK study and on August 7, 2013 submitted the clinical study report to the FDA.

SOURCE Nuvo Research Inc.