FDA Withdraws Exparel Warning Letter, Settles Free-Speech Suit By Pacira

(December 16, 2015, 2:33 PM EST) -- NEW YORK — Pacira Pharmaceuticals Inc. on Dec. 14 agreed to dismiss its free-speech lawsuit against the Food and Drug Administration for the marketing of the local anesthetic Exparel after the FDA withdrew a warning letter about off-label promotion, issued a clarifying letter and approved revisions to the Exparel approval and both parties promised to deal with each other “in an open, forthright, and fair manner” (Pacira Pharmaceuticals, Inc., et al. v. United States Food & Drug Administration, et al., No. 15-7055, S.D. N.Y.).

(Pacira settlement...
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