Regulatory

The FDA has approved AstraZeneca's Bevespi Aerosphere glycopyrrolate/formoterol fumarate MDI (formerly PT003) for the treatment of COPD, the company has announced. The product is AstraZeneca's first to use the Co-Suspension technology patented by Pearl Therapeutics in 2012. AstraZeneca acquired Pearl in 2013. Data from the Phase 3 PINNACLE trial, which was … [Read more...] about AstraZeneca’s Bevespi Aerosphere MDI approved by the FDA

The US FDA has issued four new product-specific draft guidances in April 2016 for inhalation products, including three dry powder products and one MDI. The documents include recommendations on establishing bioequivalence for generic versions of Breo/Relvar Ellipta, Arnuity Ellipta, Arcapta Neohaler/Onbreez Breezhaler, and Asmanex HFA, Read the new guidances for … [Read more...] about FDA issues product-specific draft guidances for four more inhalation products

On March 10, 2016, the Philadelphia District Office of the FDA issued a warning letter to online retailer Dr Natural Healing about sales of epinephrine capsules packaged with a dry powder inhaler as a treatment for asthma. The letter gives the company 15 working days to respond. As of March 31, the website is still offering the "Prime Asthma Relief" products for sale, … [Read more...] about FDA warns online retailer over unapproved epinephrine DPI

Mundipharma has submitted a marketing application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the flutiform fluticasone/formoterol K-Haler breath-activated MDI for the treatment of asthma, the company said. The submission will be reviewed through the decentralized procedure. In 2006, Mundipharma acquired European rights to flutiform … [Read more...] about Mundipharma submits MAA for flutiform K-Haler breath-activated MDI

According to Boehringer Ingelheim Pharmaceuticals, the FDA has approved a supplemental NDA for the Stiolto Respimat tiotropium/olodaterol SMI for a labeling change to add quality of life data obtained from the OTEMTO 1&2 studies. Stiolto Respimat, which was initially approved for the treatment of COPD by the FDA in May 2015, is approved as Spiolto Respimat in some … [Read more...] about FDA approves sNDA for Stiolto Respimat

Kamada has submitted a Marketing Authorization Application for its inhaled alpha-1 antitrypsin (AAT) therapy for the treatment of AAT deficiency to the European Medicines Agency, and the filing EMA has validated the application, the company said. In September 2014, Kamada announced that it planned to move forward with regulatory submissions for inhaled AAT despite … [Read more...] about Kamada submits MAA for inhaled AAT

The FDA has granted Qualified Infectious Disease Product (QIDP) designation to Raptor Pharmaceutical's MP-376 inhaled levofloxacin for the treatment of chronic P. aeruginosa lung infections in patients with cystic fibrosis, non-cystic fibrosis bronchiectasis (BE), and nontuberculous mycobacteria (NTM). Raptor has previously received orphan designation from the FDA for … [Read more...] about Raptor’s inhaled levofloxacin gets QIDP status

The FDA published notices on February 16, 2016 announcing publication of draft guidances titled “Allergic Rhinitis: Developing Drug Products for Treatment” and "Nonallergic Rhinitis: Developing Drug Products for Treatment. The agency says that comments should be submitted by April 18, 2016 for either draft guidance in order to be considered prior to the start of work … [Read more...] about FDA accepting comments on draft guidances for rhinitis drug development