Reuters logo
10 months ago
BRIEF-Lipocine updates on FDA meet over LPCN 1021 application
October 17, 2016 / 12:07 PM / 10 months ago

BRIEF-Lipocine updates on FDA meet over LPCN 1021 application

Oct 17 (Reuters) - Lipocine Inc

* Lipocine completes post action meeting with FDA for LPCN 1021 new drug application

* Lipocine inc - purpose of FDA meeting was to review complete response letter and to determine actions needed to achieve approval of LPCN 1021

* Says in response to FDA's letter, Lipocine proposed a dosing regimen based on analyses of existing data

* Lipocine Inc - FDA noted that while co's proposed dosing regimen might be acceptable, validation in a clinical trial would be needed prior to resubmission

* Says as a result, Lipocine has submitted new dosing validation clinical study protocol to FDA

* Says FDA has agreed to review protocol through a special protocol assessment Source text for Eikon: Further company coverage:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below