In anticipation of increased demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products is available by publishing product-specific guidances (PSGs) to support generic drug development for these drugs.
The 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. The PSG for hydroxychloroquine sulfate adds advice about a Biopharmaceutics Classification System-based biowaiver option...
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