Ed Silverman states at his Pharmalot blog on 1/4/13:
KV Pharmaceutical may have emerged from bankruptcy in hopes of marketing still more of its controversial Makena treatment for reducing the risk of premature births. But the troubled little drugmaker, which has consistently locked horns with the FDA, last week lost another battle with the agency over its efforts to fend off competition to its controversial drug.
This time, the FDA rejected a petition KV had filed in hopes of preventing agency approval of a generic version of Delalutin, an older version of Makena, or hydroxyprogesterone caproate. KV argued that the FDA should not approve a generic because this would violate its exclusive marketing rights for Makena under the Orphan Drug Act (here is the petition).
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