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SC pharma company rebuked by FDA after marketing drug as COVID-19 symptom treatment
https://www.postandcourier.com/business/sc-pharma-company-rebuked-by-fda-after-marketing-drug-as-covid-19-symptom-treatment/article_3cbac9be-070a-11eb-bb8a-231b779ad792.htmlSC pharma company rebuked by FDA after marketing drug as COVID-19 symptom treatment
By Jessica Holdman
Oct 5, 2020 Updated 15 hrs ago
WEST COLUMBIA — Nephron Pharmaceuticals is in trouble with federal regulators after its chief executive shared emails last month that pitched a children’s asthma drug as a possible treatment for COVID-19 symptoms.
The U.S. Food and Drug Administration sent a warning letter dated Sept. 22 to the West Columbia generic drugmaker, threatening regulatory action if it did not cease any marketing materials that give a “misleading impression about the safety and effectiveness of Budesonide for the treatment of COVID-19.”
“We are working diligently with FDA to resolve the matter and have no further comment at this time,” Nephron CEO Lou Kennedy said in a statement.
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