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Mallinckrodt's higher-dose Pennsaid gets 2nd FDA look, as firm faces lawsuit

This article was originally published in Scrip

Executive Summary

A day after Mallinckrodt Pharmaceuticals' partner filed a lawsuit in the US District Court for the Southern District of New York against the firm asserting breach of contract involving its Pennsaid (diclofenac sodium topical solution) products, the company said the FDA had accepted its resubmitted new drug application (NDA) for the 2% formulation of the non-steroidal anti-inflammatory drug, which previously went under the moniker MNK-395.

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