Nuvo/Mallinckrodt’s Pennsaid Setback Starts Clock On Generic Launch
This article was originally published in Pharmaceutical Approvals Monthly
With Nuvo’s new Pennsaid 2% formulation hung up at FDA, Apotex may be able to launch its generic of the old 1.5% formulation of the topical diclofenac product on April 1, 2014, under a settlement announced in January.
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Galderma pulled Pliaglis from the market in 2008 over manufacturing issues, which the specialty pharma thought were resolved when it submitted an sNDA last fall. Regulators, however, still have questions surrounding the daub on, peel off product’s manufacture, which has now been transferred from a third-party to Galderma.
Covidien says it has been working for several years towards separating out its pharma business from its larger and more profitable devices/supplies division.
Company plans to meet with FDA in early 2007 to discuss the topical non-steroidal anti-inflammatory treatment.