OINDPnews


Copley Scientific banner

Regulatory

FDA approves Sandoz albuterol MDI

The FDA is touting its June 1, 2021 approval of Sandoz's ANDA for an albuterol sulfate MDI for the treatment of asthma, saying, "The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency and has prioritized the review of generic drug applications for potential treatments and supportive therapies for patients with … [Read more...] about FDA approves Sandoz albuterol MDI

FDA accepts Liquidia’s NDA resubmission for LIQ861 dry powder treprostinil

According to Liquidia, the FDA has accepted the company's resubmitted NDA for LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension and has set a PDUFA goal date of November 7, 2021. Liquidia initially submitted the 505(b)(2) NDA in January 2020; the agency accepted the submission in April 2020 and then issued a complete response letter to the … [Read more...] about FDA accepts Liquidia’s NDA resubmission for LIQ861 dry powder treprostinil

Adherium appoints new CEO, submits 510(k) application for next generation Hailie sensor after rejecting takeover bid

Inhaler monitoring company Adherium has submitted a 510(k) application for a new Hailie sensor designed to work with the Symbicort MDI the company announced. The company recently rejected a takeover bid from another Australian asthma monitoring company called Respiri and then named a new CEO, its sixth chief executive since 2017, saying that it "must continue … [Read more...] about Adherium appoints new CEO, submits 510(k) application for next generation Hailie sensor after rejecting takeover bid

FDA sets goal date for review of Lannet’s ANDA for generic of Advair Diskus

According to Lannett, the FDA has set a GDUFA goal date of January 31, 2022 for completion of its review of the ANDA for Respirent's generic version of Advair Diskus fluticasone propionate / salmeterol DPI for the treatment of asthma and COPD. The submission of the ANDA was announced in April 2021 by Lannett, which acquired US rights to the generic version of … [Read more...] about FDA sets goal date for review of Lannet’s ANDA for generic of Advair Diskus

EMA says there is insufficient evidence that treatment with ICS can benefit COVID-19 patients

The EMA’s COVID-19 task force has said "that there is currently insufficient evidence that inhaled corticosteroids are beneficial for people with COVID-19." In addition, the task force said that "it could not exclude the possibility of harm from the use of inhaled corticosteroids in patients with COVID-19 who have normal levels of oxygen." Evidence cited by the … [Read more...] about EMA says there is insufficient evidence that treatment with ICS can benefit COVID-19 patients