Dyloject Approval Status

  • FDA approved: No
  • Brand name: Dyloject
  • Generic name: diclofenac sodium
  • Company: Javelin Pharmaceuticals, Inc.
  • Treatment for: Pain

Dyloject (diclofenac sodium injection) is an IV non-steroidal anti-inflammatory drug (NSAID) in development for the management of acute moderate-to-severe pain in adults.

FDA Approval Status for Dyloject

Feb 17, 2010Javelin Pharmaceuticals' Receives FDA PDUFA Date for Dyloject NDA
Feb  2, 2010FDA Accepts Javelin Pharmaceuticals' Dyloject New Drug Application for Formal Review
Dec  2, 2009Javelin Pharmaceuticals Submits Dyloject New Drug Application to FDA for Management of Acute Moderate-to-Severe Pain in Adults

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