Regulatory

According to Circassia Pharmaceuticals, the UK has approved the company’s generic fluticasone propionate MDI for the treatment of asthma under the European decentralized procedure. The MAA includes the same three strengths (50µg, 125µg and 250µg… Read more . . .

The FDA has approved Adapt Pharma’s Narcan naloxone nasal spray for the treatment of opioid overdoses less than four months after the submission of the company’s NDA. Lightlake Therapeutics licensed the intranasal naloxone to Adapt… Read more . . .

Novartis has announced FDA approval for the Seebri Neohaler glycopyrrolate DPI and the Utibron Neohaler indacaterol/glycopyrrolate DPI for the treatment of COPD. According to the company, both inhalers should be available in the first quarter… Read more . . .

Adapt Pharma announced that the FDA has accepted its filing and granted priority review to its New Drug Application for Narcan naloxone hydrochloride nasal spray for the treatment of opioid overdose. Adapt submitted the NDA… Read more . . .

GlaxoSmithKline and Theravance have announced plans to file a supplemental Japanese New Drug Application for the Relvar/Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment of COPD in the first quarter of 2016. The Japanese MHLW… Read more . . .

Boehringer Ingelheim’s Spiriva Respimat tiotropium soft mist inhaler has now been approved by the FDA for the treatment of asthma in patients 12 years old and older. Spiriva Respimat was approved for the treatment of… Read more . . .

Teva has announced the FDA’s acceptance of a supplemental new drug application (sNDA) for the ProAir RespiClick albuterol DPI for the treatment of asthma in patients aged 4 to 11. The FDA approved ProAir RespiClick… Read more . . .

GSK and Theravance, Inc. have announced that the Breo Ellipta fluticasone furoate/vilanterol DPI has been approved in Canada in 100/25 mcg and 200/25 mcg versions for the treatment of asthma in patients aged 18 years… Read more . . .