Regulatory

GlaxoSmithKline Consumer Healthcare has announced the approval of Flonase Allergy Relief fluticasone propionate nasal spray for the treatment of allergic rhinitis for over-the-counter (OTC) sales in Canada. The nasal spray will be available OTC for… Read more . . .

Daiichi Sankyo has announced that Japanese regulators have approved the use of its Inavir laninamivir octanoate hydrate DPI for the prevention of influenza in single doses of 20 mg for children under 10 years old… Read more . . .

According to Pulmatrix, the FDA has granted orphan drug status to the company’s PUR1900 itraconazole DPI for the treatment of fungal lung infections in cystic fibrosis patients, with the FDA stating, “Your designation is based… Read more . . .

Johnson & Johnson has announced that intransal esketamine being developed by its subsidiary Janssen Research & Development has received Breakthrough Therapy Designation from the FDA. According to J&J, the product is in Phase 3 development… Read more . . .

GSK’s Veramyst fluticasone furoate nasal spray will soon be available as an over-the-counter product marketed as Flonase Sensimist, GSK Consumer Healthcare has announced. According to the company, the FDA has approved Flonase Sensimist as an… Read more . . .

Sunovion has submitted a new drug application to the FDA for its SUN-101/eFlow glycopyrrolate for the treatment of COPD, the company said. The company recently reported positive results from the GOLDEN-5 long-term safety study of… Read more . . .

The FDA has approved St. Renatus’s Kovanaze tetracaine HCl and oxymetazoline HCl nasal spray, the company announced. The product is approved for regional anesthesia for adults and children weighing 40 kg or more who are… Read more . . .

While Health Canada conducts an expedited review of a new drug submission (NDS) for naloxone nasal spray, Minister of Health Jane Philpott has signed an Interim Order temporarily allowing naloxone nasal spray imported from the… Read more . . .

The FDA has made the approval packages for Boehringer Ingelheim’s Stiolto Respimat and Spiriva Respimat available on its website. The Stiolto Respimat tiotropium bromide/olodaterol SMI, which is marketed as Spiolto Respimat in Europe, was approved… Read more . . .

Teva has announced the FDA’s acceptance of the company’s NDAs for fluticasone propionate (FP)/salmeterol and FP monotherapy DPIs for the treatment of asthma. Both products are delivered using the breath-activated RespiClick inhaler. In late 2015,… Read more . . .