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K-V Pharmaceutical And Orphan Drug Makena: Pharmalot Blog Perspective

January 7, 2013

     The Pharmalot Blog publishes a January 4, 2013, article titled, “KV Pharma Loses Another Battle Over Makena”. A compounding pharmacy, McGuff Pharmaceuticals, wants to sell a generic version of Delalutin, an older version of Makena.

K-V Pharmaceutical files a Petition with the FDA in June 2012 against the generic version of Delalutin.  Under the Orphan Drug Act (ODA), K-V Pharmaceutical argues that the FDA should not approve a generic version because it violates the exclusive marketing rights for Makena. The FDA rejects K-V Pharmaceutical’s petition to prevent the approval of a generic version of Delalutin. The FDA rejects the petition by arguing that “approving a generic would not violate orphan drug exclusivity because the approved indication would differ from what was granted for Makena”.


K-V Pharmaceutical June 15, 2012 Petition to the FDA

McGuff Pharmaceuticals September 19, 2012 Response Letter to FDA in opposition to K-V Pharmaceutical Petition to the FDA

FDA January 2, 2013 Response Letter to K-V Pharmaceutical

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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