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Zdrowie i gospodarka · 29.07.2019

Determination That FORTAMET (Metformin Hydrochloride) Extended-Release Tablets, 500 Milligrams and 1 Gram, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that FORTAMET (metformin hydrochloride) extended-release tablets, 500 milligrams (mg) and 1 gram (g), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.

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