The U.S. Food and Drug Administration (FDA) notified Novartis [노바티스] that information the pharma company has on Facebook about its cancer drug Tasigna is misleading because it makes claims of its efficacy, but fails to note any risks.
The FDA said in a letter to the company that the content inadequately communicates Tasigna’s FDA-approved indication, and implies excellence over other competing products.
The agency also noted that Novartis [노바티스] failed to submit the marketing material as required under regulations.
Tasigna is indicated for certain forms of chronic myelogenous leukemia in adult patients resistant or intolerant to prior therapy that includes imatinib.
In light of the above, the FDA recounted that Novartis [노바티스] is to cease the dissemination of the disputable promotionals, and to furnish a written response.