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 patients 18 years old and over beginning in early 2017. GSK President of Consumer Healthcare North America Colin … [Read more...] about Flonase Allergy Relief approved for OTC sales in Canada

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 and single doses of 40 mg for anyone older than 10. Inavir was approved in Japan for the treatment of influenza A and B in 2010 and for the prevention of … [Read more...] about Japanese regulators approve additional dosage regimen for the Inavir DPI

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 on a plausible hypothesis that your drug may be clinically superior to the same drug that is already approved for the same indication." The … [Read more...] about Pulmatrix’s PUR1900 itraconazole DPI gets orphan drug designation

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 as a treatment for major depressive disorder with an imminent risk of suicide, and 6 clinical trials are currently … [Read more...] about Janssen’s intranasal esketamine gets Breakthrough Therapy Designation

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 OTC treatment for seasonal and allergic rhinitis symptoms. Veramyst was initially approved in 2007. GSK Consumer Healthcare … [Read more...] about FDA approves Flonase Sensimist OTC nasal spray

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 SUN-101/eFlow and had previously reported data from the GOLDEN-3 and GOLDEN-4 efficacy trials that are being used to support the NDA. … [Read more...] about Sunovion submits NDA for SUN-101/eFlow glycopyrrolate for COPD

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 having work done on the upper incisors, canines, or premolars. The company announced positive results from a Phase 3 study of the nasal spray in … [Read more...] about FDA approves nasal spray dental anesthetic

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 US to be sold in Canada. Currently, the only form of naloxone available in Canada is injectable. Adapt Pharma submitted the NDS to Health … [Read more...] about Health Canada allows temporary importation of naloxone nasal spray from the US

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 for the treatment of COPD by the FDA in May 2015. Spiriva Respimat tiotropium bromide SMI was approved for the treatment … [Read more...] about Approval packages for Stiolto Respimat and Spiriva Respimat now available

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, Teva announced positive data from Phase 3 studies of both products. The FDA is expected to take action on both … [Read more...] about FDA accepts Teva NDAs for fluticasone propionate/salmeterol and FP monotherapy DPIs