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
Regulatory
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
Aradigm provides update on Apulmiq (formerly Linhaliq) dual release inhaled ciprofloxacin
Aradigm Corporation says that it has scheduled a meeting with the FDA to discuss results from the Phase 3 ORBIT-3 and ORBIT-4 trials of Apulmiq (formerly Linhaliq) dual release inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients now that a third party evaluation of the results has been completed. … [Read more...] about Aradigm provides update on Apulmiq (formerly Linhaliq) dual release inhaled ciprofloxacin
Insys says it plans NDA submissions for two nasal sprays in 2019
Insys Therapeutics says that it plans NDA submissions for both its naloxone and epinephrine nasal sprays in 2019. The company also noted the potential of regulatory submission for its inhaled dronabinol in the next few years. According to Insys, a PK study of the naloxone nasal spray "showed a distinctive profile for the . . . nasal spray product candidate in … [Read more...] about Insys says it plans NDA submissions for two nasal sprays in 2019
Pharmaxis relaunches Aridol in the US
Pharmaxis said that its distribution partner Methapharm Inc. has begun selling Pharmaxis' Aridol mannitol bronchial challenge test kit again in the United States. According to the company, its Sydney, Australia manufacturing facility received FDA approval to manufacture Aridol for the US market in August 2018. Aridol is also approved in Australia, South Korea, and … [Read more...] about Pharmaxis relaunches Aridol in the US
Zambon’s inhaled colistimethate sodium gets QIDP and fast track designations
Zambon has announced that its colistimethate sodium powder for nebulized delivery as a solution by the Philips i-neb nebulizer system, has received QIDP and fast track designations from the FDA for the prevention of exacerbations in non-cystic fibrosis bronchiectasis patients with P. aeruginosa lung infections. The company said that two Phase 3 studies of … [Read more...] about Zambon’s inhaled colistimethate sodium gets QIDP and fast track designations
Auris Medical’s intranasal betahistine gets orphan drug designation, expanded development
According to Auris Medical, the FDA has granted orphan drug designation to its intranasal betahistine for the treatment of obesity associated with Prader-Willi syndrome (PWS). The company also said that it has signed a letter of intent to in-license rights to US patents covering the use of betahistine for two other indications, depression and … [Read more...] about Auris Medical’s intranasal betahistine gets orphan drug designation, expanded development
Tiziana initiates Phase 1 trial of intranasal foralumab
Tiziana Life Sciences has announced that the FDA approved the company's IND for intranasal foralumab human anti-CD3 antibody, and a Phase 1 clinical trial has begun. Tiziana licensed foralumab from Novimmune in 2014 and is developing the nasal formulation for the treatment of neurodegenerative diseases such as multiple sclerosis. The dose escalating trial, … [Read more...] about Tiziana initiates Phase 1 trial of intranasal foralumab