Shire Cited for Marketing of Its ADHD Drug Intuniv
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... Advertising and Communications over direct-to-consumer promotions for its attention-deficit hyperactivity disorder (ADHD) drug Intuniv. ...

Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lurasidone, an investigational atypical antipsychotic agent for the treatment of schizophrenia. The application, submitted on December 30, 2009, includes data from more than 40 clinical studies ...

Actavis Fails to Win FDA Change in Vyvanse Exclusivity Decision
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The FDA has affirmed five-year market exclusivity for Shire's Vyvanse — a decision generic maker Actavis is challenging in a lawsuit against the agency. ...

The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.