Lipocine announces fda labeling changes for testosterone products

Salt lake city , march 12, 2025 /prnewswire/ -- lipocine inc. (nasdaq: lpcn), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the u.s. food and drug administration (fda) has recently informed sponsors of approved testosterone products about class-wide labeling changes. this decision follows the agency's review of the findings from the testosterone replacement therapy for assessment of long-term vascular events and efficacy response in hypogonadal men (traverse) clinical trial and the results from required post market ambulatory blood pressure (abpm) studies.
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