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PDUFA June 28 2016 of LPCN 1021 for men with low testosterone
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"Our focus remains on evaluating the content of the CRL, including the FDA recommended actions, to bring our NDA for LPCN 1021 into a position for approval. We remain committed to bringing LPCN 1021 to patients who will benefit from its intended use," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine. "In addition, we continue to advance the progress of our other pipeline products, LPCN 1107 and LPCN 1111, with updates expected in the coming months."
The CRL identified deficiencies related to the dosing algorithm for the label. Specifically, the proposed titration scheme for clinical practice was significantly different from the titration scheme used in the Phase 3 trial leading to discordance in titration decisions between the Phase 3 trial and real-world clinical practice. The next step will be to request a meeting with the FDA to understand more fully the issues raised and to agree on a path forward to achieve approval of LPCN 1021.
Slingshot Insights Explained
Jun 29, 2016
- As Lipocine's LPCN-1021 nears its FDA PDUFA date for a deficiency or absence of endogenous testosterone ("hypogonadism") what is the drug's potential? LPCN, ABBV, ENDP, LLY Executed On: Jun 09, 2016 at 12:30 PM EDT
Related Keywords Pdufa, Lpcn 1021, Low Testosterone, Low-t, Nda, Trt, Testosterone Replacement Therapy, Hypogonadism