A Food and Drug Administration (FDA) advisory panel voted not to approve Lipocine Inc.’s oral testosterone replacement treatment called Tlando, citing safety concerns involving blood pressure and heart rate, hematocrit, and serum lipids. Tlando, previously known in studies as LPCN 1021, are capsules that contain 112.5 mg testosterone undecanoate, an esterified testosterone derivative, combined with a propriety lipid formulation. Once taken orally, the testosterone is systematically absorbed primarily through the lymphatic system. The FDA’s Bone, Reproductive, and Urological Drugs Advisory Committee (BRUDAC) voted six in favor and 13 against approval of the drug based on its benefit/risk profile. The FDA ... Read More
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