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Zdrowie i gospodarka · 28/07/2021

FDA Clears Fluorouracil Topical Solution for Sale

The US Food and Drug Administration (FDA) has ruled that Fluorouracil topical solution, 5 percent, was not withdrawn from sale due to safety or effectiveness concerns. This decision means the FDA will not initiate withdrawal procedures for the abbreviated new drug application (ANDA) related to this product, and will continue to approve new ANDAs as long as they meet regulatory requirements.

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