Regulatory

Mylan submitted an abbreviated new drug application (ANDA) to the FDA for its fluticasone propionate/salmeterol DPI, a generic version of GSK's Advair Diskus, for the treatment of asthma and COPD in December 2015, the company has confirmed. The application includes all of the doses for which Advair Diskus is marketed: 100, 250, and 500 μg fluticasone/50 μg salmeterol. … [Read more...] about Mylan submits ANDA for fluticasone/salmeterol DPI

The FDA has granted orphan drug designation to Neurelis's lead product, NRL-1 intranasal diazepam for the treatment of acute repetitive seizures in epilepsy patients, the company said. Biotie paid $1 million for an option to buy Neurelis and rights to the product in 2013 but returned the rights in July 2014. Neurelis President and CEO Craig C. Chambliss commented, … [Read more...] about Neurelis gets orphan drug designation for intranasal diazepam

Less than a week after the FDA approved Adapt Pharma's Narcan naloxone nasal spray for the treatment of opioid overdose, the agency has issued a Complete Response Letter to Indivior's NDA for its naloxone nasal spray, Indivior said. Indivior submitted the NDA in July 2015. According to the company, "The FDA’s response was principally focused on clinical … [Read more...] about Indivior receives Complete Response Letter for naloxone nasal spray

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 per actuation) as GSK's Flixotide fluticasone propionate MDI, and the company will now submit marketing applications in … [Read more...] about Circassia’s fluticasone propionate MDI approved in UK based on in vitro data only

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 in December 2014; Adapt submitted the NDA in July 2015; and the application was granted priority review by the FDA in September 2015. … [Read more...] about FDA approves Narcan nasal spray

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 of 2016. The company's indacaterol monotherapy DPI, marketed in the US as Arcapta Neohaler, was approved by the FDA in … [Read more...] about FDA approves Utibron and Seebri Neohaler DPIs

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 in July 2015. Lightlake Therapeutics licensed the nasal spray to Adapt in December 2014, and the FDA granted Fast Track designation for the … [Read more...] about FDA grants priority review to Adapt Pharma’s NDA for Narcan naloxone nasal spray

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 approved Relvar Ellipta for the treatment of asthma in patients 15 years old and older in September 2013. The companies also … [Read more...] about GSK and Theravance announce planned submission of Japanese sNDA for Relvar Ellipta

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 COPD in the US in September 2014, and it is currently approved for the treatment of asthma in over 50 countries. Boehringer Ingelheim Head of … [Read more...] about FDA approves Spiriva Respimat for the treatment of asthma