Ontario, Canada (CU)_ Ocugen Inc, Bharat Biotech’s partner for the US and Canadian markets, announced that its affiliate Vaccigen Ltd has started a rolling submission to Health Canada, the Canadian health regulator, for the Covid-19 vaccine Covaxin. Ocugen, Inc. is a biopharmaceutical corporation founded in 2013. The company provides advanced treatments for sight-related disorders such as ocular graft versus host disease, retinitis pigmentosa, geographic atrophy, wet age-related macular degeneration, and diabetic retinopathy. Ocugen has a vast customer base in the United States.
In a regulatory filing to the US stock exchanges, Ocugen stated, “The rolling submission process was recommended and accepted under the Minister of Health’s interim order respecting the importation, sale and advertising of drugs for use in relation to Covid-19 and transitioned to a new drug submission for Covid-19, which permits companies to submit safety and efficacy data and information as they become available”. The company added, “Often referred to as a rolling review, this allows Health Canada to start its review right away, as information continues to come in, to accelerate the overall review process. Health Canada will make a decision upon review of the evidence submitted that supports its safety, efficacy and quality”.
Dr Shankar Musunuri, chairman of the board, CEO & co-founder, Ocugen Inc appreciated Health Canada for reviewing Covaxin. He said, “We thank Health Canada for their upcoming review of Covaxin and look forward to working with them so that we can offer the possibility of another safe and effective option to be used in their fight against Covid-19 and its Delta variant”.
