Bioequivalence

Florida Court Ruling has implications for physician’s prescribing practice

A Florida State administrative judge ordered that levothyroxine sodium be taken off of the negative formulary list which had previously protected brand name thyroid hormone prescriptions As of January 26, 2008, A Florida State administrative judge ordered that levothyroxine sodium be taken off of the negative formulary list which had previously protected brand name thyroid …

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The ATA Unveils New Data to FDA On Bioequivalence of Levothyroxine

The ATA Unveils New Data to FDA On Bioequivalence of Levothyroxine Physician survey reveals significant adverse events in patients On Oct. 4, 2006, the Food and Drug Administration (FDA) heard data presented by James Hennessey, MD, representing the American Thyroid Association (ATA), at a joint meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee …

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ATA letter to FDA regarding retitration for patient well-being

ATA expresses concern to FDA regarding deletion of retitration warning after switching brands August 3, 2005 Steven Galson, M.D.Director, Center for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers Lane, HFD-240Rockville, MD 20857 Dear Dr. Galson:We are writing on behalf of the American Thyroid Association, The Endocrine Society, and the American Association of Clinical Endocrinologists …

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ATA follows up on May 23 FDA workshop

ATA writes letter to follow-up after FDA workshop June 30, 2005 Steven Galson, M.D.Director, Center for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers Lane, HFD-240Rockville, MD 20857 Dear Dr. Galson: We are writing on behalf of our societies–the American Thyroid Association (ATA), The Endocrine Society (TES), and American Association of Clinical Endocrinologists (AACE)–to follow-up …

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Agenda of Joint Public Meeting – ATA,The Endocrine Society, AACE and the FDA

Joint Public Meeting on Equivalence of Levothyroxine Sodium Products – Agenda Download Agenda (PDF File, 27KB) See related articles on Bioequivalence of Levothyroxine

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FDA workshop on bioequivalence announced in Federal Register

FDA workshop on bioequivalence co-sponsored by the ATA, The Endocrine Society, and AACE [Federal Register: April 20, 2005 (Volume 70, Number 75)] [Notices]———————————————————————– DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0137] Levothyroxine Sodium Therapeutic Equivalence; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for …

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