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# Nephron Pharma Warned on Email Unapproved Use
- URL: https://www.fdaweb.com/nephron-pharma-warned-on-email-unapproved-use/
- Published: 2020-10-05T12:00:00.000Z
- Updated: 2026-09-14T16:31:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147802

Nephron Pharmaceuticals has been issued what looks to be the first [Warning Letter](https://www.fda.gov/media/142585/download?ref=fdaweb.com) to cite a prescription drug manufacturer for promoting its product for an unapproved use in treating Covid-19\. The letter from CDER’s Office of Prescription Drug Promotion (OPDP) cited emails about Nephron’s budesonide inhalation suspension for treating Covid-19 symptoms. “These violations are concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of budesonide for the treatment of Covid-19 and suggest a use for which the labeling does not provide adequate directions for safe and effective use of the product,” the letter says.

Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to eight years of age. However, an email sent in July made the headline claim, “BUDESONIDE RELIEVES RESPIRATORY SYMPTOMS ASSOCIATED WITH COVID-19” (emphasis original). “This email also states, ‘Over the last few weeks, doctors and researchers have touted the benefits of using budesonide as a treatment for symptoms associated with Covid-19,” the letter says. “One physician, who went viral this month, called budesonide a ‘silver bullet.’”

The letter told Nephron to immediately stop misbranding budesonide or stop introducing the misbranded drug into interstate commerce.