Paxlovid (Nirmatrelvir and Ritonavir tablets) has been licensed by the US Food and Drug Administration for the treatment of mild-to-moderate Covid-19 in people who are at high risk of progressing to severe coronavirus, including hospitalization or death.

It is the fourth medicine licensed by the USFDA to treat Covid-19 in adults and the first oral antiviral tablet. MPP has announced agreements with 35 generic manufacturers worldwide to provide low-cost generic versions of Pfizers oral COVID-19 therapy Nirmatrelvir in conjunction with Ritonavir for supply in 95 low- and middle-income countries.

In India, Hetero reported in December that NIRMACOM, the worlds first generic version of Paxlovid, had acquired WHO prequalification and EUA permission from the Drugs Controller General of India to manufacture and commercialize the oral antiviral. The USFDA has approved developing generic versions of Paxlovid, which will increase the antivirals availability and accessibility.

The FDA performs a benefit-risk evaluation based on rigorous scientific criteria to verify that the products advantages outweigh its hazards for the targeted population. While the epidemic has been brutal, Patrizia Cavazzoni, head of the FDAs Centre for Drug Evaluation and Research, stated that significant progress had been achieved in minimizing the impact of COVID-19.

The antiviral is neither recommended nor authorized for use as a pre-exposure or post-exposure prophylactic for Coronavirus prevention.

(Source: https://health.economictimes.indiatimes.com/news/pharma/usfda-approves-worlds-first-oral-antiviral-for-covid-19/100513928)