Regulatory

The FDA has issued a draft guidance on the establishment of bioequivalence for ipatropium bromide metered dose inhalers. In the US, Boehringer Ingelheim markets its ipatropium MDI for the treatment of COPD under the brand name Atrovent. The recommended tests included five in vitro tests, a PK study, and a PD study. The draft guidance notes that if the reference … [Read more...] about FDA issues draft BE guidance for ipatropium bromide MDIs

Australia's Therapeutic Goods Administration (TGA) has issued a warning about devices marketed by a company called Discreet Vape that look nearly identical to metered dose inhalers used for rescue medications for asthma. The PUFFiT and PUFFiT-X devices are advertised as "the discreet choice" for smoking "dry herbal blends." Discreet Vape, based in Hong Kong, … [Read more...] about TGA warns of smoking devices that look nearly identical to MDIs

The FDA has approved Meda's Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis in children aged 6-11 "who require treatment with both components," the company said. Dymista was approved for adults and for children 12 and older in 2012. Meda submitted data from two pediatric trials to support the … [Read more...] about Meda’s Dymista gets FDA approval for children aged 6-11

The FDA has granted Adapt Pharma Fast Track designation for its intranasal naloxone for the treatment of opioid overdose, the company said. Adapt Pharma licensed the product from Lightlake Therapeutics in December 2014. In the same month, Lightlake began a new trial of the drug for the opiod overdose reversal indication. Funding for the trial has been provided by the … [Read more...] about Adapt Pharma gets Fast Track designation for intranasal naloxone

Theravance has announced that the the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug Safety and Risk Management Advisory Committee will meet jointly on March 19, 2015 to discuss whether the Breo Ellipta fluticasone/vilanterol DPI should be approved for the treatment of asthma in patients 12 and older. Theravance and GSK filed sNDA 204275-S001 in … [Read more...] about FDA advisory committees to review Breo Ellipta sNDA (updated)

Israeli biopharmaceutical company Advanced Inhalation Therapies (AIT) has announced that it received Orphan Drug Designation from the FDA last fall for its AIT-CF high dose nitric oxide formulation for the treatment of lung infections in cystic fibrosis patients. The company says that its proprietary delivery system for the 160 ppm formulation "continuously monitors … [Read more...] about Orphan Drug Designation for AIT’s nitric oxide product for CF

PARI has announced that following approval by the FDA, its eRapid nebulizer is now available for delivery of Pulmozyme dornase alfa inhalation solution for the treatment of cystic fibrosis. In Europe, the device, marketed as eFlow Rapid, has been available for use with Pulmozyme for years. The eRapid nebulizer cuts Pulmozyme delivery time to 2-3 minutes compared … [Read more...] about PARI’s eRapid nebulizer now approved for delivery of Pulmozyme in US