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First Amendment Suit From Pacira Challenges FDA Labeling Interpretation

 
• By Brenda Sandburg

Speech about specific uses is within broad approved indication of post-surgical pain medication Exparel, Pacira argues.

Following in Amarin Pharmaceuticals Inc.’s footsteps, Pacira Pharmaceuticals Inc. is trying to bypass FDA and get a court ruling okaying its promotion of the post-surgical pain treatment Exparel (bupivacaine liposome injectable suspension).

While Amarin was pursuing completely off-label speech – hoping to communicate data that FDA didn't approve – the question in...

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