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Examples

  • Asfotase alfa, currently in Phase II clinical development, received orphan-drug status in the U.S. and European Union in 2008 and fast-track status in the U.S. in 2009.

    Alexion to Acquire Enobia Pharma for Up to $1.08 Billion Tess Stynes 2011

  • In case you have forgotten the gory back story: KV Pharmaceuticals got FDA orphan-drug status for a formulation of 17-hydroxyprogesterone, a very, very old drug that was shown in 2003 to prevent recurrent preterm deliveries.

    Adam Wolfberg, M.D.: Preterm Birth and a Really Sleazy Lawsuit M.D. Adam Wolfberg 2011

  • "It's critical that we make sure this company isn't taking advantage of its orphan-drug determination to monopolize the market and engage in price gouging at the expense of pregnant women," Sen. Klobuchar said.

    Lawmakers Seek Probe of Drug for Pregnant Women Nathan Becker 2011

  • In case you have forgotten the gory back story: KV Pharmaceuticals got FDA orphan-drug status for a formulation of 17-hydroxyprogesterone, a very, very old drug that was shown in 2003 to prevent recurrent preterm deliveries.

    Adam Wolfberg, M.D.: Preterm Birth and a Really Sleazy Lawsuit M.D. Adam Wolfberg 2011

  • In case you have forgotten the gory back story: KV Pharmaceuticals got FDA orphan-drug status for a formulation of 17-hydroxyprogesterone, a very, very old drug that was shown in 2003 to prevent recurrent preterm deliveries.

    Adam Wolfberg, M.D.: Preterm Birth and a Really Sleazy Lawsuit M.D. Adam Wolfberg 2011

  • In case you have forgotten the gory back story: KV Pharmaceuticals got FDA orphan-drug status for a formulation of 17-hydroxyprogesterone, a very, very old drug that was shown in 2003 to prevent recurrent preterm deliveries.

    Adam Wolfberg, M.D.: Preterm Birth and a Really Sleazy Lawsuit M.D. Adam Wolfberg 2011

  • Suboxone's orphan-drug status in the U.S. expired in October last year, and once a generic competitor is launched its sales are expected to plummet.

    Developing Markets Buoy Reckitt Benckiser Lilly Vitorovich 2010

  • Both the European Commission, the European Union's executive arm, and the U.S. Food and Drug Administration have granted ruxolitinib orphan-drug status.

    Novartis Blood-Cancer Drug Meets Goal Anita Greil 2011

  • In case you have forgotten the gory back story: KV Pharmaceuticals got FDA orphan-drug status for a formulation of 17-hydroxyprogesterone, a very, very old drug that was shown in 2003 to prevent recurrent preterm deliveries.

    Adam Wolfberg, M.D.: Preterm Birth and a Really Sleazy Lawsuit M.D. Adam Wolfberg 2011

  • An orphan-drug designation is no guarantee a medicine will ultimately be approved for marketing.

    Push to Cure Rare Diseases Amy Dockser Marcus 2010

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