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Makena’s Orphan Exclusivity Is “Nullified” By FDA’s Compounding Policy, KV Suit Says

 
• By Brenda Sandburg

KV seeks a court order requiring FDA to desist from permitting importation of unapproved API for compounded hydroxyprogesterone and to state its intent to take enforcement action against compounders.

Facing the threat of imminent bankruptcy, Lumara Health Inc. has filed suit against FDA to try to force the company to take enforcement action compounded versions of hydroxyprogesterone caproate, the active ingredient in its pre-term birth drug Makena.

The complaint, filed July 5 in the U.S

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