U.S. Food and Drug Administration
Par Pharmaceutical Files Declaratory Judgment to Protect First Amendment Rights to Disseminate Truthful Information Regarding Megace(R) ES
Published in Managed Care Weekly Digest, October 31st, 2011
2011 OCT 31 -- Par Pharmaceutical, Inc., the wholly-owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX) announced that it filed a declaratory judgment complaint and a motion for preliminary injunction in U.S. District Court in Washington, D.C. seeking to preserve Par's First Amendment right to provide truthful information to physicians and other healthcare providers about the FDA-approved, on-label use of Par's prescription drug, Megace® ES.
In 2005, the FDA approved Megace® ES for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients diagnosed with acquired immunodeficiency syndrome (AIDS). In...
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