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Zdrowie i gospodarka · 14/08/1997

FDA Classifies Orally Administered Levothyroxine Sodium as New Drugs Due to Stability and Potency Issues

The FDA has announced that orally administered levothyroxine sodium products are considered new drugs due to significant stability and potency problems, which can lead to serious health consequences. Manufacturers have 3 years to submit new drug applications to continue marketing these products.

Source: Federal Register — Food and Drug AdministrationOpen original release →