FDA ‘Exception’ For Ipca’s Chloroquine/HCQ Amid Supply Plans From Others
Import alert hit-Ipca gets a temporary reprieve from US FDA for supplies of hydroxychloroquine sulphate and chloroquine phosphate, the antimalarials in the spotlight as potential treatments for COVID-19. But with many firms committing to supplies/donations, analysts appear to be tempering enthusiasm for large windfall gains for the Indian firm.
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Among the 53 new molecular entities cleared by FDA in 2020, Bayer’s Chagas disease therapy Lampit has a unique distinction: the approval required an in-person inspection that FDA actually conducted amid the COVID-related shutdown of routine pre-approval site visits.
India has prohibited exports of hydroxychloroquine, though with concessions in specific instances, days after a national task force recommended the drug for the prophylaxis of SARS-CoV-2 infections. Home market supplies of the drug also appear strained for now.
Development work for antivirals such as favipiravir and remdesivir seen as potential treatments for coronavirus is underway in India, with the former’s off-patent status making it more attractive. All eyes are also on data from a French study which highlights the potential of hydroxychloroquine and azithromycin as a COVID-19 treatment.