Mumbai-based pharmaceutical company Glenmark on Saturday (June 20) launched antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of mild to moderate cases of COVID-19 at ₹103 a tablet after the Drug Controller General of India (DCGI) had approved the drug for “restricted emergency use” in such cases.
Earlier, the DCGI, under the fast-tracked approval process, granted Glenmark the permission to manufacture and market favipiravir (200 mg) tablet, considering the emergency and unmet medical need for COVID-19.
The drug will be available as a 200 mg tablet at ₹3,500 for a strip of 34 tablets, Glenmark said. FabiFlu is the first oral favipiravir-approved medication in India for the treatment of COVID-19, it said in a statement.
It is a prescription-based medication, with recommended dose being 1,800 mg twice on the first day, followed by 800 mg twice daily for up to 14 days, it added. The tablets are being produced by the company at its Baddi facility in Himachal Pradesh. The drug will be available both through hospitals and the retail channel, Glenmark said.
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“This emergency use authorisation has been granted with certain conditions, which include taking written informed consent from each patient or his/her representative. Besides, the company will have to conduct active post-marketing surveillance on the first 1,000 patients to assess the safety and efficacy of the drug,” an official source said.
The marketing authorisation was given based on the interim report of phase three clinical trials to ensure early availability of the anti-viral drug in the country. While the trials are still ongoing, the DCGI approved the drug as the interim results so far have been encouraging, the source said.
The DCGI had recommended that the drug should be used only in adults and not on patients with severe liver and renal impairment and pregnant and lactating women, the source said, adding it should be used with caution in patients having a history of abnormalities in uric acid metabolism or gout.