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Pennsaid Approval History

  • FDA approved: Yes (First approved November 4th, 2009)
  • Brand name: Pennsaid
  • Generic name: diclofenac sodium
  • Dosage form: Topical Solution
  • Company: Nuvo Research Inc.
  • Treatment for: Osteoarthritis

Pennsaid is a topical non-steroidal anti-inflammatory drug (NSAID) used for the treatment of signs and symptoms of osteoarthritis of the knee.

Development History and FDA Approval Process for Pennsaid

Nov  5, 2009Approval FDA Approves Pennsaid Topical Solution
Aug  5, 2009FDA Extends Review of Pennsaid Diclofenac Sodium Topical Solution
Feb 19, 2009FDA Accepts Nuvo's Resubmission For Pennsaid
Jun 19, 2007Nuvo Provides Update on Discussions with the FDA Related to Pennsaid Approval
Jun  6, 2007Nuvo Continues Discussions with the FDA Related to Pennsaid
Mar  7, 2007Nuvo announces further update on discussions with the FDA related to review of Pennsaid
Feb  9, 2007Nuvo Announces Update on Discussions With FDA Related to Approval of Pennsaid
Dec 29, 2006Nuvo Receives Approvable Letter From U.S. FDA for Pennsaid
Jul 13, 2006Nuvo’s Pennsaid NDA Resubmission Accepted for Review by U.S. FDA

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