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Zdrowie i gospodarka · 03/03/2020

FDA Clears NEO TECT KIT for Sale, Allows for Future ANDA Approvals

The US Food and Drug Administration (FDA) has officially determined that NEO TECT KIT, a kit used to prepare Technetium Tc 99m Depreotide Injection, was not withdrawn from sale due to safety or effectiveness concerns, paving the way for future abbreviated new drug applications (ANDAs) if all regulatory requirements are met.

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