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Nuvo reports FDA response to PENNSAID 2% NDA

FDA in the letter mentioned that it requires Mallinckrodt’s complete pharmacokinetic study comparing PENNSAID 2% to original PENNSAID 1.5%. FDA denied to review the similar pharmacokinetic studies submitted

FDA accepts AMAG Feraheme sNDA for review

The sNDA filed is to expand the indication for ferumoxytol for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD), who have