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Abbott submits sNDA for new formulation of Lupron Depot in advanced prostate cancer
Thursday, March 11 2010 | Comments
What's This?
Abbott submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration requesting approval of a six-month, 45 mg formulation of Lupron Depot (leuprolide acetate) for the palliative treatment of patients with advanced prostate cancer. According to the firm, the FDA has accepted the sNDA for review.
The application was supported by data from a 48-week study that included 300 patients with prostate cancer. The participants were treated with two 45 mg injections of Lupron Depot given 24 weeks apart. Abbott said the six-month depot formulation sustained testosterone suppression throughout the study's treatment period.
The compound already is available for this indication in one-, three- and four-month depot formulations at doses of 7.5 mg, 22.5 mg and 30 mg, respectively.
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