Indivior receives Complete Response Letter for naloxone nasal spray

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 . . . Read more

Circassia’s fluticasone propionate MDI approved in UK based on in vitro data only

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 other EU member . . . Read more

Sumatriptan nasal spray shortage expected to last until February 2016

According to the FDA, GlaxoSmithKline has reported that 20 mg and 5 mg dosages of its Imitrex nasal spray for the treatment of migraine headaches will be unavailable until February 2016 due to an API shortage. The shortage, which was reported to the FDA on November 20, 2015, affects both dosages of an authorized generic . . . Read more