The FDA’s Pulmonary-Allergy Drugs Advisory Committee has scheduled discussion of a number of new drug applications for inhalation products in the next few months. The meetings are open to the public and will be available as live webcasts.
The committee will meet on January 29, 2013 to discuss the new drug application (NDA) for Boehringer Ingelheim’s olodaterol MDI (Striverdi Respimat) for the treatment of COPD. The next day, the committee will discuss the NDA for Pharmaxis’ Bronchitol mannitol inhalation powder for the treatment of cystic fibrosis. On March 7, the committee will meet regarding GSK’s Breo Ellipta fluticasone furoate/vilanterol DPI application.
In addition, a joint meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management committee will be held on March 5 to discuss whether the benefits of calcitonin salmon nasal sprays outweigh the risks.
Background material should be posted on the FDA website at least two days prior to each meeting, and the web address for the live webcasts will also be made available at least two days in advance.
Read the January 29 meeting announcement.
Read the January 30 meeting announcement.
Read the March 5 meeting announcement.
Read the March 7 meeting announcement.
