Two drug companies – both plagued by fits and starts– are racing to see which will be the first to gain Food and Drug Administration (FDA) approval for the first testosterone pill that can be taken by mouth. This week Lipocine announced it had resubmitted a New Drug Application (NDA) to the FDA for LPCN 1021, it’s oral testosterone replacement therapy designed to boost testosterone in men with low levels of the male hormone, a condition called hypogonadism. Lipocine had previously submitted an NDA to the FDA in June 2016 but was rejected. The agency cited problems with the dosing ... Read More
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