USFDA Flags Sarfez Pharma for Misleading Promotion of Torsemide Drug Soaanz
USFDA Warning
US: In a stern regulatory move, the United States Food and Drug Administration (USFDA) has issued a warning letter to Virginia-based Sarfez Pharmaceuticals, Inc. for making false and misleading claims in the promotional materials of its heart failure drug Soaanz (torsemide tablets).
The agency found that the promotional webpages, a healthcare provider pamphlet, and an exhibit panel misbranded the drug by misrepresenting both its efficacy and risk profile, violating several sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA's Office of Prescription Drug Promotion (OPDP) reviewed the promotional material disseminated during the American College of Cardiology (ACC) Annual Scientific Session & Expo in April 2024, and flagged the company for serious compliance failures. The letter, dated April 25, 2025, warns:
“The webpages, pamphlet, and exhibit panel make false or misleading claims and representations about the efficacy and risks associated with Soaanz. Thus, the webpages, pamphlet, and exhibit panel misbrand Soaanz within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and make its distribution violative.”
Key Regulatory Breaches
FDA highlighted several violations including:
Unsubstantiated claims of superiority over generic loop diuretics
Minimization of known risks such as dehydration, hypotension, and renal impairment
Failure to submit promotional materials to the FDA via Form FDA-2253 at the time of first use
Sarfez was found to have promoted Soaanz with unverified claims such as:
“SOAANZ does not cause excessive or acute urination but retains diuretic effectiveness.”
“If you have heart failure and are taking a furosemide-class diuretic, but excessive urination is affecting your daily life, try SOAANZ.”
“SOAANZ may help patients whose bladder problems get worse with the use of a generic loop diuretic.”
The FDA noted that these claims were unsupported by clinical evidence. The bioavailability study used for approval was not designed to assess bladder issues or natriuretic superiority. In fact:
“FDA is not aware of evidence to support representations and suggestions that pharmacologic differences between Soaanz and other loop-diuretic class drugs, including torsemide, result in clinically meaningful differences in diuresis... or natriuresis.”
Moreover, the risk disclosures in the exhibit panel were either omitted or insufficient:
“The exhibit panel contains claims about the benefits of Soaanz, as discussed above, but fails to include any risk information about the drug.”
The agency also pointed out the misleading nature of the statement:
“May benefit heart failure patients who feel sudden need to urinate with use of a loop diuretic”
...by noting that it omitted essential details from the approved FDA indication:
“SOAANZ is indicated in adults for the treatment of edema associated with heart failure or renal disease.”
FDA Demands Corrective Action
In its concluding remarks, the FDA demanded that Sarfez submit a corrective action plan and respond within 15 working days:
“OPDP requests that Sarfez cease any violations of the FD&C Act. Please submit a written response to this letter… and provide information to correct each of these concerns. Corrective communication(s) should be free of promotional claims and presentations.”
Failure to comply could result in regulatory enforcement.
