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How Are K-V Pharmaceutical’s Orphan Drug Makena And The US Rare Meningitis OutBreak Related ?

October 9, 2012

        The Internet is buzzing about the current US rare meningitis outbreak. Per CNN, as of October 9, 2012, 3:05 PM EDT, per the CDC, there are now 11 deaths and 119 people sickened.  The outbreak is linked to contaminated steroid injections made by the New England Compounding Center (NECC) in Massachusetts.  The compounding pharmacy has announced a voluntary nationwide recall of all its products.

        Approximately 10% of drugs administered in the US come from compound pharmacies.

        Drugs made by compound pharmacies don’t have to go through FDA-mandated premarket approval. Instead state health pharmacy boards are responsible for their oversight.

        So how is K-V Pharmaceutical’s orphan drug Makena related to this US rare meningitis outbreak ?’s October 9, 2012 article titled,”KV Pharma & Compounding: We Told You So”,  discusses how K-V Pharmaceutical is now “seizing on the controversy surrounding the New England Compounding Center …… Why ? KV Pharm has been complaining for months about the quality of some compounded versions of Makena, as well as active pharmaceutical ingredients used to make them …. The drug maker was raising safety issues about compounding alternatives for nearly 2 years …..”.  This was followed by K-V Pharmaceutical suing the FDA & 3 state Medicaid agencies. The company claimed that the FDA orphan drug exclusivity given to Makena, was not being enforced by preventing the cheaper compounding drug (equivalent to Makena) from being bought.


TheBigRedBiotechBlog October 9, 2012 article titled,” Compound(er) Errors may Bite FDA in Butt”

The Wall Street Journal October 9, 2012 article titled,”Outbreak Spurs Calls for New Controls”

Copyright © 2012-2013, Ann-Teresa Cusenza and Orphan Druganaut Blog. All rights reserved.

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