Regulatory

According to Indivior, the French regulatory agency Agence nationale de sécurité du médicament et des produits de santé (ANSM) has approved the company’s MAA for Nalscue naloxone hydrochloride nasal spray for the reversal of opioid… Read more . . .

Aradigm Corporation has filed a new drug application to for Linhaliq inhaled ciprofloxacin (formerly Pulmaquin) for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (NCFBE), the company said. The company… Read more . . .

GSK has filed a supplementary NDA for approval of a 50mcg once-daily dose of the Arnuity Ellipta fluticasone furoate DPI for the treatment of asthma in children aged 5-11. The FDA approved 100mcg and 200mcg… Read more . . .

Samumed’s SM04646 inhaled Wnt pathway inhibitor has been granted orphan drug designation by the FDA, the company has announced. The company recently announced positive Phase 1 results for SM04646, which it is developing for the… Read more . . .

GlaxoSmithKline and Innoviva have announced the filing of a submission to the EMA for the use of the Relvar Ellipta fluticasone furoate/vilanterol DPI (marketed as Breo Ellipta in the US) by patients whose asthma is… Read more . . .

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the reclassification of Nasonex mometasone furoate nasal spray from a “POM,” or “prescription only medicine,” to a “P” medicine, available over the counter at… Read more . . .

Functional respiratory imaging (FRI) specialist Fluidda has requested a Critical Path Innovation Meeting (CPIM) with the FDA as part of an initiative for approval of its FRI technology as a biomarker, the company said. According… Read more . . .

The FDA has accepted for review Sunovion’s resubmission of the NDA for SUN-101/eFlow glycopyrrolate inhalation solution for the treatment of COPD, the company said. Sunovion received a complete response letter to the previously submitted NDA… Read more . . .

Acorda Therapeutics has submitted a 505(b)(2) new drug application for Inbrija (CVT-301) levodopa for the treatment of symptoms during OFF periods in Parkinson’s disease patients, the company said. According to the company, the FDA is… Read more . . .

Boehringer Ingelheim has filed a citizen petition with the FDA asking the agency to “request the Commissioner of Food and Drugs to ensure that any New Drug Application (“NDA”) for a fixed-dose, triple-combination, inhaled drug… Read more . . .