Specialty drug maker Lipocine Inc., has launched a dosing validation study based on feedback from the Food and Drug Administration (FDA) regarding the protocol for LPCN 1021, the company’s oral testosterone replacement candidate for men with hypogonadism, a hormone deficiency condition in adult men. Lipocine had sought FDA approval earlier in 2016 but was shot down by regulators who questioned the dosing algorithm. The company responded by submitting a new dosing validation study protocol, which the FDA reviewed and approved. The special protocol assessment and validation study are needed in order to secure FDA approval. Lipocine plans to enroll 100 hypogonadal ... Read More
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