PARSIPPANY, N.J.--(BUSINESS WIRE)--Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today filed a lawsuit against the U.S. Food and Drug Administration (FDA) seeking to exercise its lawful rights to communicate truthful and non-misleading information about its flagship product, EXPAREL® (bupivacaine liposome injectable suspension). EXPAREL was approved in 2011 for administration into the surgical site to produce postsurgical analgesia.
The complaint outlines the Company’s belief that the FDA has violated the Administrative Procedure Act (APA), Fifth Amendment, and its own guidance materials and precedent by threatening enforcement action for promoting EXPAREL consistent with its approved indication. Additionally, the lawsuit alleges that the FDA violated the First Amendment rights of Pacira and the co-plaintiffs by restricting the exchange of truthful and non-misleading speech. The complaint, which was filed in the United States District Court for the Southern District of New York, can be accessed here: http://phx.corporate-ir.net/phoenix.zhtml?c=220759&p=irol-lawsuit.
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The complaint outlines the Company’s belief that the FDA has violated the Administrative Procedure Act (APA), Fifth Amendment, and its own guidance materials and precedent by threatening enforcement action for promoting EXPAREL consistent with its approved indication. Additionally, the lawsuit alleges that the FDA violated the First Amendment rights of Pacira and the co-plaintiffs by restricting the exchange of truthful and non-misleading speech. The complaint, which was filed in the United States District Court for the Southern District of New York, can be accessed here: http://phx.corporate-ir.net/phoenix.zhtml?c=220759&p=irol-lawsuit.
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