Lipocine Announces FDA Labeling Changes for Testosterone Products

Core Insights - The FDA has announced class-wide labeling changes for approved testosterone products, including the removal of the Boxed Warning related to cardiovascular risks [2][3] - The TRAVERSE trial results have led to recommendations for all testosterone products to include updated information and specific details on increased blood pressure [2] - Lipocine Inc. anticipates that these regulatory changes will positively impact its testosterone replacement therapy product and other candidates in its pipeline [3] Company Overview - Lipocine Inc. is a biopharmaceutical company focused on developing therapeutics through effective oral delivery, targeting large markets with significant unmet medical needs [4] - The company has a range of clinical development candidates, including LPCN 1154 for postpartum depression and LPCN 2401 for obesity management [5] - Lipocine has an exclusive license agreement with Verity Pharma for marketing its testosterone replacement therapy product in the U.S. and Canada [3]