Bioequivalence Articles

AACE, TES, and ATA Joint Position Statement on the Use and Interchangeability of Thyroxine Products December 8, 2004 AACE, TES, and ATAJoint Position Statement on the Use and Interchangeability of Thyroxine Products Recently, the FDA approved the use of additional thyroxine products. A press release and notice to the American Association of Clinical Endocrinologists (AACE), The Endocrine Society (TES), and American Thyroid Association (ATA) members [...]

Thyroid Experts Warn of Clinically Important Differences in Potency of FDA-Approved Levothyroxine Products Generic bioequivalence data confirms medical societies’ concern about recently approved generic levothyroxine preparations August 11, 2004 (FALLS CHURCH, VA)—Two organizations representing more than 5,400 clinical endocrinologists today warned patients taking thyroid medication, prescribing physicians, and pharmacists dispensing these drugs that clinically important differences do, in fact, exist between one recently approved generic [...]

Thyroid Experts Speak Out Against the FDA’s Decision to Approve Generic Levothyroxine Preparations FDA approval of generic levothyroxine preparations as equivalent to branded products is major concern of thyroid experts June 28, 2004 (FALLS CHURCH, VA)—Three organizations whose members specialize in the treatment of endocrine disorders recently voiced concern and dismay at the Food and Drug Administration’s (FDA) decision to approve generic substitutes for levothyroxine [...]

ATA, TES, and AACE express disappointment and concern for the health of millions of thyroid patients after FDA announces decision to approve generic substitutes for levothyroxine products June 24, 2004 The American Thyroid Association (ATA), The Endocrine Society (TES), and the American Association of Clinical Endocrinologists (AACE), representing 4,600 clinical endocrinologists, are deeply disappointed that the FDA has moved to approve generic levothyroxine preparations as [...]

ATA and Endocrine Sister Societies urge FDA to consider expert opinion and the health of millions of thyroid patients  May 26, 2004 Steven Galson, M.D.Acting Director, Center for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers Lane, HFD-240Rockville, MD 20857 Dear Dr. Galson: We are writing to you again on behalf of our societies–the American Thyroid Association (ATA), The Endocrine Society (TES), and American Association [...]

ATA, AACE and TES respond to FDA postponement of workshop March 19, 2004 Steven Galson, M.D.Acting 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 express our disappointment that FDA has [...]