Aridis Pharmaceuticals said that the EMA has granted orphan drug designation to the company's AR-501 inhaled gallium citrate for the treatment of pulmonary infections in cystic fibrosis patients. The company said that the FDA had also recently granted orphan drug designation to AR-501, also known as "Panaecin," for that indication. A Phase 1/2a study of AR-501 is … [Read more...] about EMA grants orphan drug designation to Aridis’ AR-501 inhaled gallium citrate
Regulatory
Teva’s AirDuo Digihaler approved by the FDA
The FDA has approved low, medium, and high dose versions of Teva's AirDuo Digihaler fluticasone propionate/salmeterol digital DPI for the treatment of asthma, the company said. The inhaler should be available in the US sometime next year. AirDuo Respiclick has been approved by the FDA since January 2017 and was launched in the US in April of that year. The … [Read more...] about Teva’s AirDuo Digihaler approved by the FDA
FDA accepts Insys NDA for naloxone nasal spray
Insys Therapeutics, which recently filed for bankruptcy, said that the FDA has accepted its NDA for the company's single unit dose naloxone nasal spray. In December 2018, Insys said that it planned to submit NDAs for both the naloxone nasal spray and an epinephrine nasal spray in 2019. Insys Chief Scientific Officer Venkat Goskonda said, “The FDA’s acceptance of … [Read more...] about FDA accepts Insys NDA for naloxone nasal spray
Glenmark gets CRL for Ryaltris, acquires Brazilian rights to Breezhaler DPIs
Glenmark Pharmaceuticals has revealed that the FDA issued a complete response letter to the company's NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray. The agency accepted the NDA for Ryaltris in August 2018 with a PDUFA date of March 21, 2019. According to Glenmark, the CRL references issues related to the drug master file for one of the … [Read more...] about Glenmark gets CRL for Ryaltris, acquires Brazilian rights to Breezhaler DPIs
Syqe launches cannabis inhaler in Israel
According to Syqe Medical, the company has received regulatory approval from the Israeli Ministry of Health to launch its metered-dose cannabis inhaler in Israel for the treatment of pain. The inhaler, which was previously available only for hospital use, will now be available to licensed patients. In 2016, the company announced that Teva would distribute the … [Read more...] about Syqe launches cannabis inhaler in Israel
Bevespi Aerosphere gets Japanese approval
The Japanese Ministry of Health, Labour and Welfare has approved AstraZeneca's Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD, the company said. Bevespi Aerosphere has been approved for the treatment of COPD in the US since 2016 and in the EU since December 2018. Canada and Australia have also approved the inhaler, which is … [Read more...] about Bevespi Aerosphere gets Japanese approval
Afrezza inhaled insulin approved in Brazil
The Brazilian Health Regulatory Agency (ANVISA) has approved Afrezza inhaled insulin for the treatment of diabetes, and the DPI is expected to be launched in Brazil by the end of 2019, MannKind Corporation said. MannKind announced in May 2017 that it had signed a Brazilian distribution deal for Afrezza with Biomm. Afrezza was approved by the FDA in 2014 and is … [Read more...] about Afrezza inhaled insulin approved in Brazil
According to Vectura and Sosei, Novartis has filed MAA for triple therapy DPI
Vectura Group and Sosei Group each said that they are owed $2.5 million milestone payments from Novartis after the EU accepted Novartis's MAA for its QVM149 indacaterol/glycopyrronium/mometasone furoate DPI for the treatment of asthma that is inadequately controlled. Vectura said that approval of the MAA would trigger an additional milestone payment of $5 million. … [Read more...] about According to Vectura and Sosei, Novartis has filed MAA for triple therapy DPI
Akorn’s azelastine hydrochloride nasal spray approved by the FDA
The FDA has approved an ANDA for Akorn's generic azelastine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis in patients 5 years old and older and for vasomotor rhinitis in patients 12 and older, the company said. According to the FDA web site, ANDA #207610 was submitted by Hi-Tech Pharmacal, which was acquired by Akorn in 2014. There … [Read more...] about Akorn’s azelastine hydrochloride nasal spray approved by the FDA
Nayzilam midazolam nasal spray approved by the FDA
UCB said that the FDA has approved an NDA for Nayzilam midazolam nasal spray (formerly USL261) for the treatment of seizure clusters in epilepsy patients aged and older. UCB acquired the nasal spray from former Upsher Smith subsidiary Proximagen in April 2018 and announced in August 2018 that the FDA had accepted the NDA. The midazolam nasal spray was granted … [Read more...] about Nayzilam midazolam nasal spray approved by the FDA