FDA Grants QDIP Status to Two Inhalation Products
The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) to two Bayer Healthcare products, Amikacin Inhale and Ciprofloxacin Dry Powder for Inhalation (DPI).
Amikacin Inhale (BAY 41-6551; Bayer Healthcare and Nektar Therapeutics), is an integrated drug-device combination being developed as an adjunctive therapy for intubated and mechanically ventilated patients with gram-negative pneumonias. The Amikacin Inhalation Solution is delivered by a Pulmonary Drug Delivery System (PDDS). Amikacin Inhale is being developed in two configurations, an on-vent drug-device that works within the ventilator setting, and an off-vent drug-device for extubated patients.
Ciprofloxacin DPI is a drug-device combination being evaluated to determine if the time to first pulmonary exacerbation of bronchiectasis can be prolonged, or its frequency reduced in patients with non-cystic fibrosis bronchiectasis (NCFB). The device contains Ciprofloxacin 32.5mg in a Novartis T-326 inhaler, a small, portable manually breath-activated device.
For more information call (800) 288-8371 or visit Healthcare.Bayer.com.