Reuters logo
BRIEF-Lipocine Says FDA's BRUDAC Voted 6 In Favor & 13 Against Benefit/Risk Profile Of Tlando
January 10, 2018 / 9:34 PM / 6 days ago

BRIEF-Lipocine Says FDA's BRUDAC Voted 6 In Favor & 13 Against Benefit/Risk Profile Of Tlando

Jan 10 (Reuters) - Lipocine Inc:

* LIPOCINE - FDA‘S BRUDAC VOTED 6 IN FAVOR & 13 AGAINST BENEFIT/RISK PROFILE OF CO‘S ORAL TESTOSTERONE PRODUCT CANDIDATE FOR TRT IN ADULT MALES, TLANDO

* LIPOCINE INC SAYS ‍FDA DECISION ON TLANDO NDA IS ANTICIPATED BY ASSIGNED PDUFA GOAL DATE OF MAY 8, 2018 - SEC FILING ​

* LIPOCINE INC - CONTINUE TO BELIEVE EFFICACY AND SAFETY RESULTS FROM CLINICAL STUDIES WITH TLANDO CONSISTENT WITH OTHER FDA APPROVED TRT PRODUCTS Source text: (bit.ly/2mnVzkJ) 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