On Apr. 13, 2020, the U.S. Food and Drug Administration (FDA) announced that given the increased demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA has published product-specific guidances to support generic drug development for these drugs.

The FDA published product-specific guidances (PSGs) to support generic drug development for these drugs. The new PSG for chloroquine phosphate clarifies that the product is AA rated in the Approved Drug Products with Therapeutic Equivalence Evaluations publication (Orange Book), meaning that there are no known or suspected bioequivalence problems, and no in vivo studies are necessary.