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Pennsaid Approval History

FDA Approved: Yes (First approved November 4, 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

DateArticle
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 toPennsaid 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

Further information

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