FDA Alert Curbs Enthusiasm For Hydroxychloroquine And Chloroquine
COVID-19 Treatment Should Be Limited To Clinical Trial Or Hospital Settings
A drug safety communication published by the US FDA over hydroxychloroquine and chloroquine has cooled hopes that the drugs could be used as key treatments to address the coronavirus pandemic.
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Specific guidance for ANDA sponsors on bioequivalence studies during the COVID-19 pandemic has been published by the US FDA.
Sandoz is sponsoring a major hydroxychloroquine trial while other major industry players like Teva, Mylan, Apotex, Stada and Lupin are also accelerating efforts to fight the coronavirus crisis. Accord and Wavelength Pharma have stepped up their manufacturing to meet demand, as the AAM has cancelled its annual meeting.
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.