The FDA has announced its approval of a Cipla albuterol sulfate MDI, a generic of 3M's Proventil HFA for the treatment of asthma. The FDA announcement noted that the agency recently issued a revised draft guidance for generic albuterol sulfate MDIs for products referencing Proventil HFA, as well as ProAir HFA and Ventolin HFA. Earlier this year, the FDA approved … [Read more...] about FDA approves Cipla’s generic version of Proventil HFA
Regulatory
Liquidia NDA for LIQ861 inhaled treprostinil accepted for review by FDA
Liquidia Technologies said that the FDA accepted the company’s 505(b)(2) NDA for its LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH), with a PDUFA goal date of November 24, 2020. The company announced in March 2019 that the Phase 3 INSPIRE study of the LIQ861 DPI for PAH had met its primary endpoint and then in January 2020 … [Read more...] about Liquidia NDA for LIQ861 inhaled treprostinil accepted for review by FDA
PADAC meeting for review of Trelegy Ellipta sNDA postponed
A meeting of the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) that had been scheduled for April 21, 2020 has been postponed due to the COVID-19 pandemic. No new meeting date was announced. The committee was due to discuss a supplemental NDA for GSK's Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI, for a label change to claim reduction … [Read more...] about PADAC meeting for review of Trelegy Ellipta sNDA postponed
CHMP adopts positive opinion regarding Atectura Breezhaler and Bemrist Breezhaler
At a March 27, 2020 meeting of the EMA's Committee for Medicinal Products for Human Use (CHMP), the committee adopted a positive opinion regarding the MAAs for Novartis's Atectura Breezhaler indacaterol/mometasone furoate and a duplicate inhaler, Bemrist Breezhaler. Both will be available in 125 mcg/260 mcg, 125 mcg/127.5 mcg and 125 mcg/62.5 mcg strengths for the … [Read more...] about CHMP adopts positive opinion regarding Atectura Breezhaler and Bemrist Breezhaler
Vero Biotech gets okay for expanded access to its Genosyl DS iNO system to treat COVID-19 patients
Vero Biotech has announced that the FDA will allow expanded access to the company's Genosyl DS tankless inhaled nitric oxide (iNO) delivery system so that it can be used for the treatment of cardiopulmonary symptoms of COVID-19. According to Vero, the system can be used in either hospital or home settings. The FDA approved Genosyl iNO for the treatment of persistent … [Read more...] about Vero Biotech gets okay for expanded access to its Genosyl DS iNO system to treat COVID-19 patients
Patient advocacy group expresses support for FDA approval of Savara’s Molgradex inhaled GM-CSF
The PAP Foundation, a US organization that advocates for pulmonary alveolar proteinosis (PAP) patients, says that it supports FDA approval of Savara's Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). The group said that it expressed this opinion at the FDA's Rare Disease Day in February 2020 and is officially submitting … [Read more...] about Patient advocacy group expresses support for FDA approval of Savara’s Molgradex inhaled GM-CSF
Nephron Pharmaceuticals looking to increase inhalation solution and suspension production capacity
Nephron Pharmaceuticals CEO Lou Kennedy spoke to local reporters in the company's home state of South Carolina on March 17, 2020, describing the company's efforts to increase production of its inhalation solutions and suspensions to meet demand during the COVID-19 pandemic. Nephron produces its own inhalation products; including albuterol, ipratroprium bromide, … [Read more...] about Nephron Pharmaceuticals looking to increase inhalation solution and suspension production capacity
Insmed submits NDA for Arikayce in Japan, announces COVID-19 measures
Insmed has announced its submission of a new drug application to Japan's Ministry of Health, Labour and Welfare (MHLW) for Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who have not responded to other therapies sufficiently. Arikayce was approved by the … [Read more...] about Insmed submits NDA for Arikayce in Japan, announces COVID-19 measures
Beyond Air submits IDE for use of its inhaled NO delivery system for COVID-19
Beyond Air said that it has submitted an investigational device exemption (IDE) to the FDA seeking to use its cylinder-free LungFit BRO inhaled nitric oxide (iNO) delivery system for the treatment of COVID-19. Beyond Air has been developing the LungFit BRO system for the treatment of bronchiolitis. The company said that if the FDA approves the IDE, it will conduct … [Read more...] about Beyond Air submits IDE for use of its inhaled NO delivery system for COVID-19
Fluidda’s Broncholab FRI platform cleared by FDA for clinical use
Functional respiratory imaging (FRI) company Fluidda announced that the FDA has cleared the company's Broncholab FRI platform for use in clinical settings. According to the company, Broncholab can provide much more accurate information about patient-specific regional lung function than conventional test methods like spirometry, allowing for better diagnosis and … [Read more...] about Fluidda’s Broncholab FRI platform cleared by FDA for clinical use