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Zdrowie i gospodarka · 02/06/2021

FDA Clears SANDOSTATIN for Sale, Citing Lack of Safety or Effectiveness Concerns

The FDA has determined that SANDOSTATIN (octreotide acetate) injection, equal to 0.2 mg/mL and 1 mg/mL, was not withdrawn from sale due to safety or effectiveness concerns. This decision means the FDA will not initiate procedures to withdraw approval of ANDAs referencing this drug product, and will continue to approve new applications as long as they meet regulatory requirements.

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