DARA Petitions FDA To Amend Label For Tamoxifen Citrate And Soltamox

(RTTNews) - DARA BioSciences, Inc. (DARA) Wednesday petitioned the U.S. Food and Drug Administration to amend the label for tamoxifen citrate and Soltamox (tamoxifen citrate), the only FDA-approved liquid bioequivalent of tamoxifen, by increasing the recommended duration of adjuvant therapy for women with estrogen receptor-positive breast cancer from five to 10 years.

Tamoxifen citrate has long been the standard adjuvant endocrine treatment for pre-menopausal women with estrogen receptor-positive breast cancer.

Recent data from multinational randomized clinical trials, the ATLAS and aTTom studies, prompted the American Society of Clinical Oncology and the National Comprehensive Cancer Network to update their clinical practice guidelines, extending the duration of adjuvant tamoxifen therapy from five to 10 years.

DARA BioSciences introduced the U.S. market to Soltamox (tamoxifen citrate), the only FDA-approved liquid formulation of tamoxfien, to provide women a therapeutic option for their breast cancer therapy.