COVID-19: Cipla launches remdesivir under brand name Cipremi in India
Cipla has been granted regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need.;
Mumbai: Cipla Limited has announced the launch of remdesivir under its brand name CIPREMI. The U.S. FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc. for emergency use of remdesivir for the treatment of hospitalized 2019 coronavirus disease (COVID-19) patients.
It is the only U.S. FDA approved Emergency Use Authorisation (EUA) treatment for adult and pediatric patients hospitalized with suspected or laboratory-confirmed COVID-19 infection. In May, Gilead Sciences Inc. extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla's generic version of remedisvir called CIPREMI.
Cipla has been granted regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need.
"As part of a risk management plan, Cipla will provide training on the use of the drug, informed patient consent documents, conduct post-marketing surveillance as well as conduct a Phase IV clinical trial on Indian patients", Cipla said in its recent release.
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