The FDA has approved an Aurobindo ANDA for generic albuterol (salbutamol) sulfate inhalation solution and, while the agency did not issue a press release, the news was included in the FDA's COVID-19 "Daily Roundup" and was promoted by agency social media accounts. Although the FDA does not currently list albuterol sulfate inhalation solution on its drug shortages … [Read more...] about FDA approves Aurobindo’s generic albuterol sulfate inhalation solution, cites “increased demand” for albuterol inhalers due to COVID-19
Regulatory
Beyond Air to initiate trial of its LungFit iNO system for COVID-19
According to Beyond Air, the company has received permission from the FDA to initiate a clinical study of its LungFit inhaled nitric oxide system for the treatment of COVID-19 patients. The announcement comes almost a month after the company said that it had submitted an investigational device exemption application to the FDA for that purpose. The company said that it … [Read more...] about Beyond Air to initiate trial of its LungFit iNO system for COVID-19
FDA issues EUA allowing B. Braun infusion pumps to be used with nebulizers
German medical device company B. Braun Medical announced that the FDA has issued Emergency Use Authorization (EUA) of several of the company's infusion pumps for "tracheal delivery of continuous nebulized medications into a nebulizer to treat patients of all ages with or suspected of having the Coronavirus Disease 2019 (COVID-19) and to decrease the exposure of … [Read more...] about FDA issues EUA allowing B. Braun infusion pumps to be used with nebulizers
FDA approves Cipla’s generic version of Proventil HFA
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 The FDA announcement noted that the agency recently issued a revised draft guidance for generic albuterol sulfate MDIs for products referencing Proventil HFA, as well as ProAir HFA and Ventolin HFA.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
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