It will be available under the brand name FabiFlu as a prescription-based medication for Rs 103 per tablet, with recommended dose of 1,800 mg twice a day on day 1 and 800 mg twice a day up to 14th day, according to the Mumbai-headquartered global pharmaceutical company.
The company on Thursday had announced in a statement that it has got approval for the antiviral drug Favipiravir for the treatment of Covid-19. Favipiravir (FabiFlu) is the first approved drug for Coronavirus in India.
In an official statement the company said on June 19, ‘Glenmark Pharmaceuticals has just received the manufacturing and marketing approval from India’s drug regulator to launch the oral antiviral drug Favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India.
This approval has been granted based on the evaluation of data and in consultation with the Subject Expert Committee, as part of the accelerated approval process, considering the emergency situation and unmet medical need of the COVID-19 outbreak.’
The company also said that the drug will be available for ‘restricted emergency use in India’ and said in the statement, 'Restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation,'
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A report by PTI said that the approval of the drug was based on an interim report of phase three clinical trials. A source in the report said that Drug Controller General of India DCGI approved the drug even while the trial was ongoing as the interim results so far have been encouraging.
Favipiravir is backed by strong clinical evidence, showing encouraging results in patients with mild to moderate Covid-19. It offers broad spectrum RNA virus coverage with clinical improvement noted in 20-90 plus age group.
Last month the company had announced that it was conducting phase 3 clinical trials of Favipiravir as a COVID-19 with 150 patients, enrolled from 9 leading government and private hospitals across the country.