FDA Makes Broad Concessions In Settling Pacira Promotion Suit

Agency will formally rescind Exparel warning letter and expand labeling to clarify that pain drug is not limited to any specific surgery.

In a resounding victory for Pacira Pharmaceuticals Inc., FDA has agreed to formally withdraw its warning letter objecting to the promotion of Exparel (bupivacaine liposome injectable suspension) and to approve a labeling supplement specifying that the post-surgical pain treatment is not limited to any specific surgery or site.

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