On February 3, 2011, the Food and Drug Administration approved the drug Makena (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. KV Pharmaceuticals, the drug\u2019s owner, received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug\u2019s effectiveness. It also obtained seven years of exclusivity under the Orphan Drug Act, obtained approval under FDA\u2019s accelerated approval program, and received expedited review.<\/p>\n","protected":false},"excerpt":{"rendered":"
On February 3, 2011, the Food and Drug Administration approved the drug Makena (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. KV Pharmaceuticals, the drug\u2019s owner, received considerable assistance from the federal government in connection with the development of Makena … Continue reading FDA Issues Statement on Makena<\/span>