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news.Enteris BioPharma has congratulated Tarsa Therapeutics on the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for TBRIA (calcitonin-salmon [rDNA origin] delayed release tablets) in July 2015, which has now been accepted for review by the FDA with a user fee goal date of May 30, 2016.
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TBRIA is a once-daily oral recombinant salmon calcitonin tablet for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause when alternative treatments are not suitable (e.g. patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
Tarsa’s formulation of TBRIA uses proprietary, patented oral delivery technology licensed from Enteris BioPharma. Tarsa has exclusive development and worldwide commercialization rights to the oral calcitonin product developed with Enteris’ technology, with the current exception of China.