Regulatory

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 . . .

According to Kentucky-based AntiOp, the company has received Fast Track designation from the FDA for its intranasal naloxone for the reversal of opioid overdose. The company is co-developing the unit-dose nasal spray, its only product,… Read more . . .

Teva has announced that the FDA has accepted its new drug application for an albuterol dry powder inhaler for the treatment of asthma in patients aged 12 and older. In October 2013, Teva indicated that… Read more . . .