DUBLIN, May 28, 2010 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter today from Zydus Pharmaceuticals USA, Inc. ("Zydus") advising of the filing of an Abbreviated New Drug Application ("ANDA") for a generic version of Shire's 1.2g mesalamine delayed release tablets, LIALDA(R).
Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced the results of a study evaluating the safety and efficacy of Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years. The data, presented in an oral session at a national scientific meeting of ...
Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, will present scientific data on its Attention Deficit Hyperactivity Disorder (ADHD) treatments Vyvanse®
Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) approved a change to the prescribing information for its once-daily Attention Deficit Hyperactivity Disorder (ADHD) treatment Vyvanse®
Shire plc (LSE: SHP, NASDAQ: SHPGY ), the global specialty biopharmaceutical company, announces that the United States District Court for the District of Columbia ("Court"), following extensive briefing by the parties and an oral hearing, has upheld the decision of the U.S. Food and Drug Administration ("FDA") to grant 5-year New Chemical Entity ("NCE") exclusivity to lisdexamfetamine dimesylate ...