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FDA Approves New Label Changes for Tirosint-SOL, Expanding Administration Options

Announced on December 04, 2023, the approved label changes allow for administration regardless of timing of proton pump administration and for administration 15 minutes before breakfast.

Food And Drug Administration Grants Two New Label Changes To Tirosint®-Sol (Levothyroxine Sodium) Or

New FDA-approved label updates offer patients more flexible administrationPARSIPPANY, N.J. (BUSINESS WIRE) The U.S. Food and Drug Administration (FDA) has approved two new changes to the label of Tirosint-SOL (levothyroxine sodium) oral solution, a unique formulation of levothyroxine (LT4) for the treatment of hyp.

FDA Approves 2 Label Changes to Levothyroxine Sodium for the Treatment of Hypothyroidism

The approval marks levothyroxine sodium as the only FDA-granted LT4 therapy that does not have a labeled interaction with PPIs and can be taken 15 minutes prior to eating breakfast.

Food And Drug Administration Grants Two New Label Changes To Tirosint®-Sol (Levothyroxine Sodium) Oral Solution

Food And Drug Administration Grants Two New Label Changes To Tirosint®-Sol (Levothyroxine Sodium) Oral Solution
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