Zydus gets DCGI emergency use approval for Virafin to treat moderate COVID-19 cases

Zydus gets DCGI emergency use approval for Virafin to treat moderate COVID-19 cases

FPJ Web DeskUpdated: Friday, April 23, 2021, 04:11 PM IST
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Zydus Biotech Park | (PTI Photo)

Zydus Cadila on Friday announced that the company had received Restricted Emergency Use Approval from the Drug Controller General of India (DCGI) for the use of ‘Virafin’, Pegylated Interferon alpha-2b (PegIFN) in treating moderate COVID-19 infection in adults.

A single-dose subcutaneous regimen of the antiviral Virafin will make the treatment more convenient for the patients. When administered early on during COVID, Virafin will help patients recover faster and avoid much of the complications. Virafin will be available on the prescription of a medical specialist for use in hospital/institutional setup.

In the multicentric trial conducted in 20-25 centers across India, Virafin had shown lesser need for supplemental oxygen, clearly indicating that it was able to control respiratory distress and failure which has been one of the major challenges in treating COVID-19. The drug has also shown efficacy against other viral infections.

Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Limited said “The fact that we are able to offer a therapy which significantly reduces viral load when given early on can help in better disease management. It comes at a much-needed time for patients and we will continue to provide them access to critical therapies in this battle against COVID-19.”

Meanwhile, Zydus Cadila on Friday said it has received final approval from the US health regulator to market anti-arrhythmic drug Propafenone Hydrochloride extended release tablets.

Propafenone is known as an anti-arrhythmic drug. It works by blocking the activity of certain electrical signals in the heart that can cause an irregular heartbeat.

Zydus Cadila has received final approval from the USFDA to market Propafenone Hydrochloride extended release capsules USP in strengths 225 mg, 325 mg, and 425 mg, Zydus Cadila, part of Cadila Healthcare group, said in a BSE filing.

The company said the drug will be manufactured at the group's formulation manufacturing facility at the special economic zone (SEZ), Ahmedabad .

The group now has 315 approvals and has so far filed over 400 abbreviated new drug applications since the commencement of the filing process in financial year 2003-04.

Shares of Cadila Healthcare were trading 1.18 per cent higher at Rs 558.75 apiece on BSE.

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