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Dr. Reddy’s Laboratories Canada Inc., on behalf of a consortium, has filed an application with Health Canada seeking authorisation for Reeqonus (favipiravir) tablets for the acute treatment of mild to moderate COVID-19 adult patients. “Dr. Reddy’s is working closely with Health Canada for an expedited review of the drug application as speed to market is essential”, VP and general manager Vinod Ramachandran said. “If approved, it will launch the product soon for COVID-19 patients in Canada,” he added.
Dr. Reddy’s Canada has filed the application on behalf of the consortium comprising Dr. Reddy’s Laboratories, Appili Therapeutics and Global Response Aid FZCO (GRA) under Health Canada’s interim order “respecting the importation, sale and advertising of drugs for use in relation to COVID-19.”
Dr Reddy s labs, its subsidiaries announces filing application for REEQONUS™ (favipiravir) Tablets
Hyderabad, Dec 22 (UNI) Dr. Reddy’s Laboratories Limited, along with its subsidiaries together referred to as “Dr. Reddy’s”, Appili Therapeutics and Global Response Aid FZCO (GRA) on Tuesday announced that Dr. Reddy’s Canada has filed an application on behalf of the consortium for REEQONUS™ (favipiravir) Tablets.
The REEQONUS™ (favipiravir) Tablets was for the acute treatment of mild to moderate COVID-19 adult patients under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
REEQONUS™ is also known as Avigan® (favipiravir) Tablets developed by FUJIFILM Toyama Chemical Company Limited, the Pharma Company said in a release here.
Representational image.
Dr. Reddy s is working closely with Health Canada for an expedited review of the drug application, says Vinod Ramachandran, Vice President and General Manager, Dr. Reddy’s Laboratories Canada Inc
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.
Dr Reddy s seeks approval for Covid drug in Canada
By IANS |
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Tue, Dec 22 2020 12:57 IST |
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US coronavirus death toll mounts to 6, Trump wants vaccine at âmaximum speedâ.. Image Source: IANS News
Hyderabad, Dec 22 : Dr Reddy s Laboratories Ltd, Appili Therapeutics and Global Response Aid FZCO (GRA) on Tuesday announced that Dr Reddy s Canada has filed an application on behalf of the consortium for Reeqonus (favipiravir) tablets for acute treatment of mild to moderate COVID-19 adult patients.
The application has been filed under Health Canada s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19, Hyderabad-headquartered pharma major Dr Reddy s said in a statement.
Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, HHS issued a final rule intended to govern the administrative dispute process in the 340B Drug Pricing Program. Read more about the rule and other news below.
I. Regulations, Notices & Guidance
On December 8, 2020, the Food & Drug Administration (FDA) issued guidance entitled,
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products. This draft guidance describes best practices to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. The draft guidance also describes the framework FDA uses i