MUMBAI: The US Food and Drug Administration on Thursday approved the world’s first oral antiviral drug. pax robid (nirmatrevir and ritonavir tablets) pax robidUS Biggie Pfizer It is the fourth drug and first oral antiviral drug approved by the US government. USFDA To treat Covid-19 in adults. So far, Paxlovid has been marketed in the United States under an Emergency Use Authorization (EUA).
The pandemic is currently in its epidemic stage and oral treatments or tablets are considered a potential game changer for mild to moderate infections.
Cipla, Dr Reddy’s, Torrent, Hetero, Biocon, Emcure, Granules India, Glenmark, and Sun Pharma last year signed an agreement with a pharmaceutical patent pool for the manufacture of generic drug substances and generic products. Overall, 35 generic manufacturers worldwide have signed contracts with his MPP to produce low-cost generic versions. Pfizerof the oral COVID-19 treatment nirmatrelvir plus ritonavir will be supplied to 95 low- and middle-income countries.
In India, Hetero announced that the world’s first generic version of Paxlovid, “NIRMACOM,” received WHO pre-approval in December. The Hyderabad-based company has also obtained EUA approval from the Directorate General of Medicines Regulatory of India to manufacture and market oral antivirals here.Now USFDA A green light would further boost the production of generic drugs, which in turn would improve the availability and accessibility of antiviral drugs. Earlier this year, demand for Pax Lovid surged in China, resulting in massive demand for the generic version in India.
Under the Federal Food, Drug, and Cosmetic Act of the United States, approval of new drugs requires, among other things, substantial evidence of efficacy and demonstration of safety for the drug’s intended use. When considering drug approval, the FDA conducts benefit-risk assessments based on rigorous scientific criteria to ensure that the benefits of the product outweigh the risks for the intended population.
“While the pandemic is a difficult time for all of us, we have made significant progress in mitigating the impact of COVID-19 on our lives,” he said. Patrizia Cavazzoni, Director of the FDA Center for Drug Evaluation and Research. “Today’s approval confirms that paxlovid has met the agency’s stringent standards for safety and efficacy, and that it has progressed to severe COVID-19, including those who were previously immune. It shows that it remains an important treatment option for people at high risk.”
Please note that this antiviral drug is not approved or licensed for use as a pre-exposure or post-exposure prophylaxis for the prevention of coronavirus.