Regulatory

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

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

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

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

The FDA's Pulmonary‐Allergy Drugs Advisory Committee (PADAC) has voted to recommend approval of Chiesi's NDA for Bronchitol DPI for the treatment of cystic fibrosis in adult patients. According to Bronchitol developer Pharmaxis, Chiesi re-submitted the NDA in December 2018. Bronchitol is already approved in Australia, Russia, and in Europe, where it was okayed in … [Read more...] about PADAC votes to recommend approval of Bronchitol

According to Glenmark Pharmaceuticals, the Russian Ministry of Healthcare has approved the company's Momate Rhino mometasone furoate nasal spray for over-the-counter sales for the treatment of allergic rhinitis in adults. Glenmark Pharmaceuticals Senior VP and Head,"Asia, Russia & CIS region, Csaba Kantor commented, "Glenmark has built strong capabilities in … [Read more...] about Glenmark gets Russian approval for Momate Rhino nasal spray

The FDA has announced the final approval of Teva's ANDA for a generic naloxone hydrochloride nasal spray. According to the announcement, the agency tentatively approved the ANDA in June 2018. Opiant Pharmaceutical's Narcan nasal spray was approved in a 4 mg dose version by the FDA in November 2015, and a 2 mg dose version of Narcan was approved in January 2017. … [Read more...] about FDA approves first generic of Narcan nasal spray

According to Synspira Therapeutics, the company's SNSP113 inhaled glycopolymer for the treatment of cystic fibrosis has received orphan drug desination from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP). The FDA granted orphan drug designation to SNSP113 in October 2018. The company said that it has received funding from … [Read more...] about Synspira’s inhaled glycopolymer for CF gets orphan drug designation in EU