FDA Goes Straight To Final Guidance For Generic Chloroquine
Allows Quick Coronavirus Response As Agency Also Issues Hydroxychloroquine Guidance
Product-specific guidances for generic versions of chloroquine and hydroxychloroquine have been issued by the FDA. Final guidance for chloroquine has been published without a draft version due to the need for speedy action amid the COVID-19 outbreak.
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Specific guidance for ANDA sponsors on bioequivalence studies during the COVID-19 pandemic has been published by the US FDA.
Major generics companies have donated hydroxychloroquine sulfate doses for research and treatment of coronavirus. Companies are also donating hand sanitizer and personal protective equipment and are preparing to ramp up manufacturing and production.
To meet expected demand in the weeks and months ahead, Novartis' Sandoz has committed to donate up to 130 million doses of generic hydroxychloroquine – a treatment for malaria currently under investigation as a therapy to aid in the COVID-19 pandemic – while Teva and Mylan have also made strides, as the generics industry continues to play its part in tackling the coronavirus outbreak.