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February 10, 2014
08:17 EDTDARADara says abstract accepted for conference presentation
DARA BioSciences announced that the company's abstract entitled Compliance and Preference for Tamoxifen Registry, or CAPTURE, patient survey reveals potential strategies to improve long-term adherence to TAM based on choice: results of a large internet-based survey" has been accepted for poster presentation at the upcoming National Comprehensive Cancer Network 19th Annual Conference: Advancing the Standard of Cancer Care. The abstract has been selected for poster presentation during General Poster Session One on March 13. David J. Drutz M.D., DARA's CEO and Chief Medical Officer said, "We are very pleased to have our CAPTURE abstract accepted by this prominent, oncology-focused organization. Our goal for initiating CAPTURE was to generate important, patient-centric information regarding demographics and medication compliance of breast cancer patients taking tamoxifen tablets, including their expressed potential preference for a liquid formulation. We look forward to reporting the data from this study and believe the key findings will raise awareness of opportunities to help improve long-term compliance with this life-saving therapy."
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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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