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March 5, 2014
08:17 EDTDARADara signs agreement with WellCare for Soltamox formulary status
DARA BioSciences announced that the company signed a Medicare Part D Prescription Drug Program Reimbursement Agreement with Comprehensive Health Management, providing formulary status for the WellCare Group of companies for Soltamox oral solution. DARA holds exclusive U.S. marketing rights to Soltamox.
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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