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U.S. Department of Health and Human Services

Drugs

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Public Meeting for Levothyroxine Sodium Therapeutic Equivalence May 23, 2005, Washington, DC

The Food and Drug Administration (FDA) is announcing a public meeting on the therapeutic equivalence of levothyroxine sodium drug products. This meeting is being held in co-sponsorship with three medical societies: The American Thyroid Association (ATA), the Endocrine Society, and the American Association of Clinical Endocrinologists (AACE). The purpose of the public meeting is to discuss FDA's regulatory standards and methodological approaches for determining therapeutic equivalence between levothyroxine sodium drug products.

Extension of comment period.  FDA is extending until September 23, 2005 the time to submit written or electronic comments in response to the May 23, 2005 public meeting on the therapeutic equivalence of levothyroxine sodium drug products. (7/22/2005)