May 9, 2018 / 3:57 PM / 14 days ago

BRIEF-Cosmo Pharmaceuticals Says Receives Letter From FDA On Methylene Blue MMX

May 9 (Reuters) - Cosmo Pharmaceuticals NV:

* RECEIVED A LETTER FROM FDA AS PART OF THEIR ONGOING REVIEW OF COMPANY’S NEW DRUG APPLICATION

* AGENCY HAS IDENTIFIED DEFICIENCIES

* COSMO PHARMACEUTICALS - DEFICIENCIES PRECLUDE CONTINUATION OF DISCUSSION OF LABELING AND POST MARKETING REQUIREMENTS AT THIS TIME Source text for Eikon: Further company coverage: (Gdynia Newsroom)

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