Lipocine Inc. has received a Complete Response Letter (“CRL”) from the FDA regarding its New Drug Application (“NDA”) for Tlando, the Company’s oral testosterone product candidate for testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. A CRL is a communication from the FDA that informs…
Major Amendment To Oral Testosterone NDA Extends FDA Review
U.S. FDA extends review for Tlando; advisory committee meeting date of January 10, 2018 remains unchanged. Lipocine Inc., a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for Tlando, the company’s oral testosterone product candidate for the proposed indication of testosterone…