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Meridian Lab Announced Positive Outcome from Pre-NDA Meeting with FDA
1 February, 2016
Meridian Labs is a specialty pharmaceutical company focusing on the development of cancer treatments through formulation improvements.
Meridian’s proprietary liquid formulation of docetaxel injection for the treatment of multiple form of cancer contains Captisol to eliminate Polysorbate 80. The in-vitro study data from CycloLab submitted to FDA show the pharmacology properties of the new formulation, and similarity to taxotere. FDA accepted the plan for the submission of New Drug Application (NDA).
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