Regulatory

Lannett Company has received FDA approval for its sumatriptan nasal spray, a generic version of GSK's Imitrex nasal spray. The company cites IMS statistics showing that US sales of sumatriptan nasal spray totaled $62 million in 2015. Lannett CEO Arthur Bedrosian commented, "We believe our sumatriptan nasal spray USP, 5 mg/spray and 20 mg/spray will be a … [Read more...] about FDA approval for Lannett’s generic version of Imitrex nasal spray

The FDA has accepted Mylan's abbreviated new drug application for its generic fluticasone propionate/salmeterol DPI and has set a GDUFA goal date of March 28, 2017, the company said. Mylan filed the ANDA for the generic version of GSK's Advair Diskus in January 2016. Mylan CEO Heather Bresch commented, "The FDA's acceptance of our ANDA filing is an important … [Read more...] about GDUFA date for Mylan’s generic Advair set for March 2017

The FDA has approved Avanir Pharmaceuticals' intranasal sumatriptan for the treatment of acute migraines, the company said. The product, which Avanir licensed from OptiNose in 2013, will be marketed in the US as Onzetra Xsail. Avanir submitted an NDA for the product, then known as AVP-825, in January 2014 and received a complete response letter from the FDA in … [Read more...] about Avanir’s Onzetra Xsail intranasal sumatriptan approved by FDA

Acerus Pharmaceuticals has received approval from Health Canada to market Natesto nasal gel as a testosterone replacement therapy in adult males with hypogonadism, and the product should be available in Canada by mid-2016, the company said. Acerus President and CEO Tom Rossi said, “Natesto addresses many of the gaps with current testosterone replacement therapies. … [Read more...] about Health Canada approves Natesto nasal testosterone gel

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