Nuvo Research Inc. (NRI.TO) said its U.S. licensing partner, Mallinckrodt, the Pharmaceuticals Business of Covidien (COV), has received a complete response letter or CRL from the U.S. Food and Drug Administration or FDA, following the review of Mallinckrodt's New Drug Application or NDA for diclofenac sodium topical solution, 2% w/w (PENNSAID 2%).
The FDA, in the letter, requires that Mallinckrodt successfully complete a pharmacokinetic study comparing PENNSAID 2% to original PENNSAID 1.5%. Mallinckrodt has indicated to Nuvo that it expects to complete the study and submit the results to the FDA in the third calendar quarter of 2013, and that it expects the FDA to provide a formal response to the filing within 6 months thereafter.
"While we are disappointed that PENNSAID 2% will not be approved in this review cycle, we are pleased that the FDA has outlined a clear pathway to approval that we believe can be completed in a relatively short time frame," said Bradley Galer, President of Nuvo's Pain Group. Galer added, "Upon approval, PENNSAID 2% will be the first and only topical NSAID in the U.S. featuring twice per day dosing and a metered dose pump bottle."
PENNSAID 2% is a follow-on product to original PENNSAID which is currently marketed in the U.S. by Mallinckrodt under license from Nuvo. PENNSAID 2% is a topical nonsteroidal anti-inflammatory drug containing 2% diclofenac sodium compared to 1.5% for original PENNSAID.
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