Regulatory

The FDA has issued a new draft guidance titled “Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment,” a revision of a 2007 draft guidance with the same title. Among other changes, the 2016 revision includes… Read more . . .

The FDA has approved Teva’s supplemental NDA for ProAir RespiClick albuterol breath-activated DPI for the treatment or asthma in children aged 4 to 11, the company has announced. The sNDA filing was accepted by the… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .