Applications to the FDA for orphan drug status for Marshall Protocol medications

Autoimmunity Research FoundationNon-profit foundation dedicated to exploring a pathogenesis and therapy for chronic disease. has submitted multiple applications to the Office of Orphan Products Development, a division of the FDA. The goal of submitting these applications would be to make it easier for doctors to prescribe and harder for insurance companies to deny coverage of MP medications.

Minocycline

submitted by ARF (September 2005) - Application for Orphan Drug Status for minocycline in sarcoidosis
FDA approval (March 2006) - minocycline as an orphan drug for sarcoidosis

Clindamycin

submitted by ARF (September 2005) - Application for Orphan Drug Status for clindamycin in treatment of sarcoidosis and Post-Treatment Lyme Disease Syndrome
FDA approval (August 2006) - clindamycin as an orphan drug for sarcoidosis

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Olmesartan

submitted by ARF (July 2006) - Application for Orphan Drug Status for olmesartan in treatment of Post-Treatment Lyme Disease Syndrome
application pending

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applications, FDA, orphan drugs