This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2013
  • /
  • 08
  • /
  • FDA filing of aclidinium bromide/formoterol fumara...
Drug news

FDA filing of aclidinium bromide/formoterol fumarate delayed.

Read time: 1 mins
Last updated:16th Aug 2013
Published:16th Aug 2013
Source: Pharmawand

Forest Laboratories, and Almirall will delay the planned fourth quarter 2013 submission of a New Drug Application for the combination of aclidinium bromide, a long acting muscarinic antagonist and formoterol fumarate, a long acting beta agonist, for the indication of Chronic Obstructive Pulmonary Disease .

This decision was based on comments provided by the FDA at a recent pre-NDA meeting. The delay is related to resolving chemistry, manufacturing and control specifications associated with the combination formulation.

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.