Drug Approval | December 28, 2021
Sun Pharma receives DCGI approval for Molxvir in India
The product is expected to be available in a week’s time
The product is expected to be available in a week’s time
DCGI approved the drug based on the review of clinical data
The drug will be marketed under the brand name Molnaflu
The recommendation was made by the Indian SARS-CoV-2 Genomics Sequencing Consortium (INSACOG), a network of national testing labs set up by the government to monitor genomic variations of Covid-19
The UK’s Medicine and Healthcare products Regulatory Agency has already approved the booster dose of AstraZenenca’s Covid-19 vaccine, which is administered in India
Preclinical data demonstrate sotrovimab, authorised in multiple countries around the world, retains activity against all tested variants of concern, including key mutations of Omicron
The Drug Controller General of India (DCGI), is reviewing clinical data of molnupiravir for the treatment of Covid-19 in adults in India
Applications remain under review by others including U.S. Food and Drug Administration and the European Medicines Agency
Filing marks first protein-based vaccine submitted to MHRA for authorization
Study to explore heterologous regimen of COVID-19 vaccines from different manufacturers in adolescents 12-16 years of age
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