Oral NONTOXIC Testosterone under review by FDA

[Vitamin_C]

Old thread revived because Lipocine resubmits LPCN 1021 to FDA. Statement from Lipocine...

"Resubmission of this NDA as planned is an important milestone in bringing LPCN 1021 to patients," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "We believe the results from the recently completed DV study address the label-related deficiency identified by the FDA in the CRL. We consider LPCN 1021 to be a differentiated TRT option for treating hypogonadism in men. We anticipate a six-month review by the FDA with a projected PDUFA date in the first quarter of 2018 assuming the FDA acknowledges our submission is a complete response."

I would be interested in following this study. I am submitting projects for NP school with an emphasis and specialty in TRT and all the studies I found using oral testosterone were using oral Testosterone Undecanoate.