FDA WARNING_LETTER - Sage Pharmaceuticals, Inc. - April 24, 2025

The FDA's Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to Sarfez Pharmaceuticals, Inc. regarding promotional materials for SOAANZ® (torsemide) tablets, including two webpages, a healthcare provider pamphlet, and an exhibit booth panel. These materials were found to make false or misleading claims about Soaanz's efficacy and risks, misbranding the drug under the FD&C Act.

Specifically, the promotional materials misleadingly suggest Soaanz is "specially formulated" to reduce peak urination and does not cause excessive or abrupt urination, implying superiority over other loop diuretics, which is not supported by the bioavailability study. The study did not reflect urination frequency/urgency or support claims of reduced excessive urination, as mean urine volume was similar to other torsemide products. The pamphlet selectively presented data to suggest lower acute diuresis, omitting contradictory information. Claims that Soaanz mitigates "bladder issues" or "hypokalemia" are also misleading, as the bioavailability study was not designed to assess bladder-related benefits, and the PI indicates Soaanz can cause hypokalemia. Furthermore, claims about maintaining natriuretic efficacy are unsupported by the cited study, which had a limited sample size and did not involve target patient populations.

The exhibit panel omitted material risk information and failed to disclose the full FDA-approved indication, which includes treatment for edema associated with renal disease, not just heart failure. The webpages and pamphlet misleadingly minimized serious risks of excessive urination, such