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The FDA has issued a draft guidance on the establishment of bioequivalence for ipatropium bromide metered dose inhalers.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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .