Inhalation Quick Links – March 2010

MannKind’s Insulin Afrezza Fails to Win Approval 3/15/10 – FDA did not cite safety concerns but requested updated safety data.

FDA Grants Bayer HealthCare Pharmaceuticals Orphan Drug Designation for Investigational Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis 3/11/10

FDA Approves Cayston(R) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa 2/22/10

FDA Safety Communication:  New Safety Requirements for Long-Acting Beta-Agonists (LABAs) 2/18/10

Tagged as: asthma, cystic fibrosis, dry powder inhaler, insulin