India says Pfizer Covid vaccine not recommended for emergency use at this stage
Vials of Pfizer Covid-19 vaccine
(REUTERS)Premium
India s drug regulator committee on Pfizer Covid-19 vaccine says it noted side effects reported abroad and causality of events are being investigated
The committee also says Pfizer did not propose any plan to generate safety and immunogenicity data in Indian population
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India s Central Drugs Standard Control Organization (CDSCO) s expert committee on Friday said that it does not recommend granting permission for emergency use authorization of Pfizer s Covid-19 vaccine in the country at this stage.
updated: Feb 05 2021, 14:59 ist
Pfizer Inc said on Friday it had withdrawn an application for emergency-use authorisation of its Covid-19 vaccine in India, after failing to meet the drug regulator s demand for a local safety and immunogenicity study.
The decision means the vaccine will not be available for sale in the world s two most populous countries, India and China, in the near future. Both countries are running their immunisation campaigns using other products.
Unlike other companies conducting small studies in India for foreign-developed vaccines, Pfizer had sought an exception citing approvals it had received elsewhere based on trials done in countries such as the United States and Germany.
Dr Reddy’s launches generic version of Sabril tablets in US
February 02, 2021
Will have180-day Competitive Generic Therapy exclusivity to market the product Dr Reddy’s Laboratories Ltd has launched Vigabatrin Tablets, a therapeutic equivalent generic version of Sabril (vigabatrin) tablets approved by the US Food and Drug Administration (USFDA).
“We are pleased that this product has been designated as a Competitive Generic Therapy (CGT) by the FDA,” Marc Kikuchi, Chief Executive Officer, North America Generics, Dr Reddy’s Laboratories, said in a release on Tuesday. “With a CGT designation, we have 180-day CGT exclusivity to market this product,” he added.
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