Regulatory

According to Bausch Health and Glenmark, Health Canada has approved Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis in people aged 6 and older. Bausch Health acquired the Canadian rights to Ryaltris in March 2021. Ryaltris has been approved in Australia since December 2019, in Europe since April 2021 and in the US … [Read more...] about Health Canada approves Ryaltris nasal spray for the treatment of seasonal allergic rhinitis

According to CanSino Biologics, China's National Medical Products Administration (NMPA) has approved the company's Convidecia Air nebulized COVID-19 vaccine as a booster dose. In December 2021, CanSino Bio announced a deal with Aerogen for the use of Aerogen vibrating mesh nebulizers for delivery of the adenovirus vector vaccine. … [Read more...] about China okays emergency use of CanSinoBio’s Convidecia Air inhaled COVID-19 vaccine

According to Bharat Biotech, Indian regulators have cleared its iNCOVACC (BBV154) intranasal vaccine against COVID-19 for use in adults aged 18 and older under a Restricted Use in Emergency Situation. Following the approval, Bharat Bio said, "the product will be launched and available for use in due course of time." Bharat Bio announced in September 2020 that it … [Read more...] about India clears Bharat Biotech’s iNCOVACC intranasal COVID-19 vaccine for emergency use

The FDA has published notice of an online meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to take place on November 8, 2022 for the purpose of discussing Avillion and AstraZeneca's NDA (214070) for PT027 albuterol / budesonide MDI for the treatment of asthma in patients aged 4 and older. The agency accepted the NDA in May 2022. According to the … [Read more...] about PADAC schedules meeting to discuss Avillion’s NDA for PT027 albuterol / budesonide MDI 

According to Lupin, the MHRA has approved company's Lutio tiotropium bromide inhalation powder, a generic version of Boehringer Ingelheim's Spiriva Handihaler. The approval is the second for a Lupin OINDP in the UK; the MHRA approved the company's Luforbec beclometasone / formoterol MDI for the treatment of asthma and COPD, a generic of Chiesi's Fostair, in June 2021, … [Read more...] about Lupin’s Lutio tiotropium bromide DPI approved for the treatment of COPD in the UK

Adherium has submitted a 510(k) application for use of its next generation Hailie inhaler monitoring sensor with Teva's ProAir albuterol MDI and its generic albuterol HFA MDI, the company said. Recently, the company filed a 510(k) submission for use of the Hailie sensor with GSK's Ventolin, Advair, and Flovent MDIs, and the FDA cleared the Hailie sensor for use with … [Read more...] about Adherium submits 510(k) for Hailie sensor use with Teva MDIs

According to Savara, the MHRA has granted Promising Innovative Medicine (PIM) designation to the company's molgramostim inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The PIM designation indicates that the product could be eligible for the UK's early access to … [Read more...] about Savara’s molgramostim for aPAP gets PIM designation from the MHRA

According to Lupin, the FDA has approved the company's ANDA for a generic version of Mylan's Perforomist formoterol fumarate inhalation solution. Teva launched a generic equivalent in the US in June 2021 after expiration of the final patent covering Perforomist, and the agency approved Alembic Pharmaceuticals' ANDA for its Perforomist equivalent in November 2021. … [Read more...] about FDA approves Lupin’s formoterol fumarate inhalation solution