Ahead of accelerated approval withdrawal hearing, Covis asks FDA to omit study potentially linking Makena and cancer
It’s been almost 10 months since the FDA granted Covis Pharma a hearing to review its controversial preterm birth drug Makena, which won an accelerated approval but failed its confirmatory trial, and still the company and FDA are wrangling over the details of that hearing.
In a letter dated Thursday, Covis lawyers from Sidley are now objecting to the hearing, including a publication that suggests a potential link between Makena and cancer in the offspring.
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