www.fdanews.com/articles/175301-depomed-petition-urges-fda-to-stay-approvals-of-nucynta-er-andas
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Depomed Petition Urges FDA to Stay Approvals of Nucynta ER ANDAs
February 11, 2016
A Depomed citizen petition claims pending ANDAs for Nucynta ER don't comply with FDA rules.
Citing a recently amended use code, Depomed is urging the FDA to stay final approvals of tapentadol ANDAs that rely on a section viii statement, rather than a patent certification for its’130 patent. The new use code completely overlaps both of the drug's indications, making it impossible to carve them out of the label via a section viii statement, it argues.
Depomed updated the code after purchasing the drug from Johnson & Johnson last March because it found that the ’130 patent claims “were actually much broader than what was reflected in the use code then on file in the Orange Book.”