Lipocine Announces [ADVERSE] Outcome of FDA Advisory Committee

[Michael Scally MD]

Lipocine Announces [ADVERSE] Outcome of FDA Advisory Committee Meeting for TLANDO™, Testosterone Replacement Therapy in Adult Males with Hypogonadism
http://files.shareholder.com/downloads/AMDA-2BVSIV/5854126997x0x968478/039b130c-42d8-4171-b45c-afa58bff4302/LPCN_News_2018_1_10_General_Releases.pdf

SALT LAKE CITY, Utah, Jan. 10, 2018 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced that the Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the U.S. Food and Drug Administration ("FDA") VOTED SIX IN FAVOR AND THIRTEEN AGAINST THE BENEFIT/RISK PROFILE of 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. The role of BRUDAC is to provide recommendations to the FDA.

The FDA decision on whether or not to approve the TLANDO New Drug Application ("NDA") is anticipated by the assigned Prescription Drug User Fee Act ("PDUFA") goal date of May 8, 2018.

 

[Nissan]

A day prior, the same FDA panel also voted 10-9 against approving a similar oral testosterone product Jatenzo by Clarus Therapeutics.
This was the second advisory committee review for both TLANDO & Jatenzo

 

[Michael Scally MD]

 

[Michael Scally MD]

FDA Documents ... https://www.fda.gov/AdvisoryCommittees/WhatsNew/default.htm%3FPage%3D3?Page=4

https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM591571.pdf

https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM591569.pdf