July 07, 2014
KV Lawsuit Involving MAKENA and Compounded 17p Concludes . . . . In Sopranos Style
By Kurt R. Karst –
The years-long, knock-down, drag-out fight between the K-V Pharmaceutical Company (“KV”) – now known as Lumara Health Inc. – and FDA (and the Department of Health and Human Services) involving KV’s pre-term birth orphan drug MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL, has ended. But that ending is more akin to the final scene from the hit HBO series “The Sopranos” than the final scene from ABC’s “Lost.” In the former, viewers were treated to a “cut to black” final scene leaving some to feel cheated. In the latter, there was at least some final resolution of what happened to the “survivors” of Oceanic Airlines Flight 815.
Last week, just before the Independence Day holiday, KV and FDA filed a Joint Stipulation of Dismissal With Prejudice with the U.S. District Court for the District of Columbia to dismiss the litigation. The case is now over and we’ll never know what might have been had the court issued a merits decision. We’re also left hanging as to what (if anything) KV got out of a deal to settle the case.
continue to read here
The years-long, knock-down, drag-out fight between the K-V Pharmaceutical Company (“KV”) – now known as Lumara Health Inc. – and FDA (and the Department of Health and Human Services) involving KV’s pre-term birth orphan drug MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL, has ended. But that ending is more akin to the final scene from the hit HBO series “The Sopranos” than the final scene from ABC’s “Lost.” In the former, viewers were treated to a “cut to black” final scene leaving some to feel cheated. In the latter, there was at least some final resolution of what happened to the “survivors” of Oceanic Airlines Flight 815.
Last week, just before the Independence Day holiday, KV and FDA filed a Joint Stipulation of Dismissal With Prejudice with the U.S. District Court for the District of Columbia to dismiss the litigation. The case is now over and we’ll never know what might have been had the court issued a merits decision. We’re also left hanging as to what (if anything) KV got out of a deal to settle the case.
continue to read here
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