January 29, 2018 / 12:15 PM / 3 months ago

BRIEF-FDA Declines To Approve Aradigm's Drug Linhaliq

Jan 29 (Reuters) - Aradigm Corp:

* ARADIGM RECEIVES COMPLETE RESPONSE LETTER FROM THE FDA FOR LINHALIQ NDA

* ARADIGM CORP - CRL STATES THAT FDA HAS DETERMINED THAT IT CANNOT APPROVE LINHALIQ NDA IN ITS PRESENT FORM

* ARADIGM - FDA’S AREAS OF CONCERN ON LINHALIQ NDA INCLUDE CLINICAL DATA, HUMAN FACTORS VALIDATION STUDY AND PRODUCT QUALITY

* ARADIGM - CRL ALSO INCLUDED REQUEST TO CONDUCT ANOTHER HUMAN FACTORS STUDY TO SHOW THAT LINHALIQ PRODUCT PACKAGING & INSTRUCTIONS FOR USE ARE EFFECTIVE

* ARADIGM - CRL REQUESTED ADDITIONAL PRODUCT QUALITY INFORMATION WITH RESPECT TO MICROBIOLOGY & A NEW IN VITRO DRUG RELEASE METHOD DEVELOPMENT REPORT

* ARADIGM CORP SAYS “WILL REQUEST A MEETING WITH FDA TO DISCUSS TOPICS COVERED IN THE CRL” 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