FDA Accepts NDA for Review for Lower Dose Submicron Diclofenac
Iroko Pharmaceuticals announced that the FDA has accepted for review its New Drug Application (NDA) for lower dose submicron diclofenac, a non-steroidal anti-inflammatory drug (NSAID), with a proposed indication of treatment of mild to moderate acute pain in adults.
The submission for the lower dose submicron diclofenac was based on data from a Phase 3 multi-center, randomized, study conducted in 428 otherwise healthy adults who developed significant pain following surgery. Patients treated with lower dose submicron diclofenac (18mg and 35mg) experienced significant pain relief post surgery compared with placebo (P=0.01 and P<0.001 respectively).
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