版本:
中国

BRIEF-Lipocine updates on FDA meet over LPCN 1021 application

Oct 17 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:

更多 公司新闻(英文)

热门文章

编辑推荐

文章推荐