Regulatory

The FDA published notices on February 16, 2016 announcing publication of draft guidances titled “Allergic Rhinitis: Developing Drug Products for Treatment” and “Nonallergic Rhinitis: Developing Drug Products for Treatment. The agency says that comments should… Read more . . .

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… Read more . . .

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… Read more . . .

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.… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .