FDA publishes guidelines for chloroquine-related COVID-19 drugs

April 14, 2020

Given the anticipated increase in demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products is available for patients. Some of these steps include the following actions: 

·        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. The revised PSG for hydroxychloroquine sulfate adds advice about a Biopharmaceutics Classification System-based biowaiver option. 

·         The FDA is also currently prioritizing review of any newly submitted Abbreviated New Drug Applications (ANDAs) for chloroquine phosphate and hydroxychloroquine sulfate under MAPP 5240.3: Prioritization of the Review of Original ANDAs, Amendments and Supplements. 

·         The FDA issued a Consumer Update: How You Can Make a Difference During the Coronavirus Pandemic. It explains ways to help, such as donating blood, protecting yourself and others, saving protective equipment for front line workers and reporting fraudulent products to the agency. 

·         The FDA added new questions and answers to the webpage Q&A for Consumers: Hand Sanitizers and COVID-19. These new questions focus on unintentional ingestion of hand sanitizer by children, as there has been an increase in calls to Poison Control for unintentional ingestion of hand sanitizer during the COVID-19 pandemic.

·         The FDA issued an Emergency Use Authorization (EUA) for the emergency use of the Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES (“B. Braun Space and Outlook Pumps”) for use in the tracheal delivery of continuous nebulized medications into a nebulizer to treat patients of all ages with or suspected of having COVID-19 and decrease the exposure of healthcare providers to such patients during the COVID-19 pandemic. The EUA was also issued for ground medical transport use of the Infusomat Space Volumetric Infusion Pump System. 

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