Regulatory

According to the FDA, the agency has issued a tentative approval of an application by PulmoFlow, Inc. to market tobramycin 300 mg/5 ml inhalation solution. PulmoFlow, Inc. was established in Virginia in 2013. The company’s… Read more . . .

Sandoz has announced that the Mexican health authority, COFEPRIS, has approved the company’s marketing application for the Airflusal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and for COPD. Three dosage levels were approved: 50-100… Read more . . .

GlaxoSmithKline has announced that it has received FDA approval for its fluticasone furoate DPI, to be marketed as Arnuity Ellipta, for the maintenance treatment of asthma. The approval is for 100mcg and 200mcg doses and… Read more . . .

The FDA has accepted Boehringer Ingelheim’s New Drug Application for its tiotropium/olodaterol Respimat soft mist inhaler for the treatment of COPD, the company has announced. BI’s Striverdi Respimat olodaterol SMI was approved by the FDA… Read more . . .

The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 10-3 to approve Boehringer Ingelheim’s Spiriva Respimat tiotropium soft mist inhaler for the treatment of COPD. BI’s first NDA submission for tiotropium Respimat took place in… Read more . . .

The FDA has announced the approval of Boehringer Ingelheim’s Striverdi Respimat olodaterol SMI for the treatment of COPD. The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended approval of Striverdi Respimat in January 2013. The soft… Read more . . .

GlaxoSmithKline has announced that the FDA has approved its Flonase fluticasone propionate nasal spray for the treatment of allergic rhinitis for over-the-counter sale. The approval is for a 50 mcg spray, the same as the… Read more . . .

GlaxoSmithKline has announced that the Australian Therapeutic Goods Administration (TGA) has approved the Incruse Ellipta umeclidinium DPI for the treatment of COPD. Incruse Ellipta was approved in Canada and in Europe in April 2014 and… Read more . . .