Manufacturing and marketing approval granted as part of accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India
In a landmark development for COVID-19 patients in India, Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company, today announced the launch of antiviral drug Favipiravir (brand name FabiFlu®) for the treatment of mild to moderate COVID-19 patients. Glenmark has received manufacturing and marketing approval from India's drug regulator, making FabiFlu® the first oral Favipiravir-approved medication in India for the treatment of COVID-19.
Commenting on the significance of this development, Mr. Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd., said, "This approval comes at a time when cases in India are spiralling like never before, putting a tremendous pressure on our healthcare system. We hope the availability of an effective treatment such as FabiFlu® will considerably help assuage this pressure, and offer patients in India a much needed and timely therapy option."
Glenmark successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu® through its own in-house R&D team. Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu® use. The drug will be available as a prescription-based medication, with recommended dose being 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14.
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