FDA of­fers guid­ance for gener­ic drug de­vel­op­ers of hy­drox­y­chloro­quine, chloro­quine

The FDA on Mon­day is­sued two new prod­uct-spe­cif­ic guid­ance doc­u­ments for the un­proven but high­ly de­mand­ed po­ten­tial Covid-19 drugs chloro­quine phos­phate and hy­drox­y­chloro­quine sul­fate.

The two gener­ic drugs, ap­proved by FDA as malar­ia drugs, have been tout­ed by Pres­i­dent Don­ald Trump in press con­fer­ences dur­ing the pan­dem­ic, but clin­i­cal tri­al da­ta re­gard­ing their ef­fi­ca­cy for COVID-19 re­main thin.

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