The FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee met on February 12, 2019 to consider Janssen's NDA for its esketamine nasal spray for the treatment of treatment-resistant depression in adults and voted in favor of approval. On the question, "Has the Applicant provided substantial evidence … [Read more...] about FDA advisory committee recommends approval of Janssen’s intranasal esketamine
Regulatory
FDA clears IND for Phase 2 study of Pulmazole itraconazole DPI
The FDA has cleared Pulmatrix's investigational new drug application, giving the company the go-ahead to begin a Phase 2 clinical trial of Pulmazole (PUR1900) inhaled dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients. In November 2018, Pulmatrix said that it planned to initiate a Phase 2 trial by the end … [Read more...] about FDA clears IND for Phase 2 study of Pulmazole itraconazole DPI
AIT Therapeutics gets milestone payment from Circassia on completion of pre-submission meeting for AirNOvent
AIT Therapeutics said that it has received a $3.15 million milestone payment from Circassia Pharmaceuticals after successful completion of a pre-submission meeting with the FDA for AirNOvent nitric oxide delivery system. Circassia recently announced that it had acquired US and Chinese rights to the product. In a separate announcement, Circassia said that it will … [Read more...] about AIT Therapeutics gets milestone payment from Circassia on completion of pre-submission meeting for AirNOvent
FDA approves Mylan’s generic version of Advair Diskus
The FDA announced that it has approved Mylan's generic version of Advair Diskus fluticasone propionate/salmeterol DPI for the treatment of asthma in patients four years old and older and for the treatment of COPD. Three strengths were approved: FP 100 μg/salmeterol 50 μg, FP 250 μg/salmeterol 50 μg and FP 500 μg/salmeterol 50 μg. In 2013, the FDA issued a draft … [Read more...] about FDA approves Mylan’s generic version of Advair Diskus
Aradigm announces submission of responses to EMA Day 120 questions
Aradigm Corporation, which submitted an MAA for its dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients in March 2018, has announced that it submitted responses to EMA Day 120 questions on January 23, 2019. The company said that it anticipates receiving a Day 180 list of … [Read more...] about Aradigm announces submission of responses to EMA Day 120 questions
FDA approves Promius’s Tosymra sumatriptan nasal spray
The FDA has approved Promius Pharma's Tosymra sumatriptan nasal spray (formerly known as DFN-02) for the treatment of migraine, Promius parent company Dr. Reddy's has announced. The company submitted an NDA for the nasal spray in April 2018. Dr. Reddy's Laboratories Co-Chairman and CEO G.V. Prasad commented, “We are excited about the approval of Tosymra. This … [Read more...] about FDA approves Promius’s Tosymra sumatriptan nasal spray
FDA publishes model DFL to encourage development of OTC naloxone nasal spray
FDA Commissioner Scott Gottlieb has issued a statement detailing steps that the agency is taking to encourage development of an over the counter naloxone nasal spray, including the publication of a model drug facts label (DFL). Gottlieb said, "I personally urge companies to take notice of this pathway that the FDA has opened for them and come to the Agency with … [Read more...] about FDA publishes model DFL to encourage development of OTC naloxone nasal spray
FDA approves Inbrija inhaled levodopa for the treatment of Parkinson’s disease
The FDA has approved Acorda's Inbrija levodopa DPI for the treatment of OFF episodes in Parkinson's disease patients taking carbidopa/levodopa, the company said. Inbrija is expected to be available to patients in the US in the first quarter of 2019. Acorda initially submitted a 505(b)(2) NDA for Inbrija in June 2017, and the FDA issued a refuse to file letter in … [Read more...] about FDA approves Inbrija inhaled levodopa for the treatment of Parkinson’s disease
FDA approves ProAir Digihaler
According to Teva, the FDA has approved the company's sNDA for ProAir Digihaler dry powder albuterol smart inhaler for the treatment or prevention of bronchospasm in patients aged 4 and over. The FDA initially approved Teva's ProAir Respiclick albuterol DPI in 2015, and the agency approved ProAir Respiclick for pediatric use in 2016. The company said that a … [Read more...] about FDA approves ProAir Digihaler
The EC approves AstraZeneca’s Bevespi Aerosphere MDI
The European Commission has approved AstraZeneca's Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD, the company has announced. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding the MAA for Bevespi Aerosphere in October 2018. The FDA approved Bevespi Aerosphere in 2016, and the … [Read more...] about The EC approves AstraZeneca’s Bevespi Aerosphere MDI