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Monday, March 04, 2019 11:17:42 AM
LPCN’s TLANDO is not competition at this time because it is not approved.
Lipocine has received Complete Response Letters (CRL’s) from the FDA for TLANDO both times they applied for approval. The letter last year called for data from an ambulatory blood pressure monitoring study that would provide "definitive evidence" that Tlando, a testosterone replacement therapy, offers clinically meaningful increases in blood pressure for men who have deficiencies of the hormone. Regulators also want Lipocine to confirm the reliability of testosterone and maximum serum concentration (Cmax) data connected to Tlando, and to explain why the pre-specified Cmax secondary endpoints for the drug aren't applicable here. Additionally, Lipocine must come up with stopping criteria that adequately identify patients who should discontinue Tlando treatment.
Antares’ Xyosted is a relatively painless self-administered weekly auto-injection to the abdomen as shown here:
https://www.xyosted.com/application/files/8515/4335/5813/IFU-_FINAL.pdf
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