FDA Says Sales Aid for Soltamox Omits Important Risk Information

The Food and Drug Administration has told DARA BioSciences Inc. that a sales aid for Soltamox (tamoxifen citrate) oral solution is misleading because it omits material facts, contains unsubstantiated superiority claims, and omits important risk information, according to an “untitled” letter posted Jan. 3 on the FDA’s website.

Soltamox is approved for treating breast cancer in adjuvant and metastatic settings and to reduce risks of breast cancer in women with ductal carcinoma in situ (DCIS) and reduce breast cancer incidence in women at high risk.

The drug is associated with a number of serious risks, some of which have been ...