Hyderabad based Dr Reddy's seeks approval from Health Canada for Favipiravir
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Dr Reddy's Laboratories Ltd, Canada-based Appili Therapeutics and Dubai-based Global Response Aid FZCO (GRA) on Tuesday said Dr Reddy's Canada has filed an application on behalf of the consortium for Reeqonus (favipiravir) Tablets for treating COVID-19 in the North American country.
The application was filed under Health Canada's "Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19," a release from the city-based drug maker said.
Reequnus is also known as Avigan (favipiravir) Tablets developed by Fujifilm Toyama Chemical Co., Ltd. "We are pleased to work with our partners at GRA and Appili to be the first in Canada to file an application for oral solid tablets for COVID-19 treatment under Health Canadas Interim Order," Vinod Ramachandran Vice President and General Manager, Dr. Reddys Laboratories Canada Inc said.
Dr. Reddy's is working closely with Health Canada for an expedited review of the drug application, as speed to market is essential in these unprecedented times. If approved, the drug will be launched soon to benefit the lives and health of COVID-19 patients in Canada, he said.
"Our role remains to design rigorous trials to obtain the data that identify COVID-19 patients that may benefit from Reeqonus. We look forward to working with our partners in providing information to Health Canada with the goal of advancing this important innovation for patients," Armand Balboni, Chief Executive Officer of Appili Therapeutics said.
"Our outreach to Canada is a part of our global efforts to play an active role in addressing the COVID-19 situation. The filing is a testimony to our commitment of bringing a potential solution to COVID-19 for the Canadian population, Chief Executive Officer of GRA, Mitch Wilson said.
In September, the Interim Order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 was signed by the Minister of Health in Canada to create a new authorization pathway that will help expedite the authorization of drugs and vaccines for COVID-19.
According to Health Canada, Reeqonu (favipiravir) Tablets are the first oral solid dosage form submitted under the Interim Order for the acute treatment of mild to moderate COVID-19 adult patients.
