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News Breaks
January 3, 2014
12:10 EDTDARADara BioSciences issued FDA 'untitled letter' over promotion of Soltamox
Dara BioSciences was sent an untitled letter, dated Dec. 20, related to a sales aid for Soltamox that the FDA said was misleading, according to a post to the FDA website. Reference Link
News For DARA From The Last 14 Days
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October 29, 2014
06:11 EDTDARADara BioSciences petitions FDA to amend label for tamoxifen citrate, Soltamox
DARA BioSciences petitioned the FDA to amend the label for tamoxifen citrate and Soltamox, 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. DARA submitted its Citizen's Petition under section 10.30 of the Federal Food, Drug and Cosmetic Act. According to the process, the FDA typically provides an initial response within 6 months of filing. Tamoxifen is indicated for the treatment of metastatic breast cancer, adjuvant treatment of breast cancer, the reduction of risk of invasive breast cancer in women with ductal carcinoma in situ, and to reduce breast cancer incidence in high risk women. More than 1.9M prescriptions of tamoxifen are written annually in the United States.

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