Regulatory
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GlaxoSmithKline plc (LSE:GSK) and Innoviva have announced that the planned submission of an NDA for a triple therapy DPI for the treatment of COPD has been moved up from the first half of 2018 to… Read more . . .
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California-based Innovus Pharmaceuticals announced that it has signed a manufacturing agreement for its FlutiCare fluticasone propionate nasal spray in anticipation of FDA approval, which it expects in the 3rd quarter of 2016. No details were… Read more . . .
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According to Teva Pharmaceutical, a decentralized procedure for its Braltus tiotropium bromide DPI for the treatment of COPD has reached “a positive conclusion.” The tiotropium formulation is delivered using the new Zonda inhaler, the company… Read more . . .
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Perrigo and Hikma subsidiary West-Ward Pharmaceuticals have launched an OTC fluticasone propionate nasal spray, a generic version of Flonase, in the US after receiving approval for the product from the FDA, the companies said. The… Read more . . .
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The FDA has issued a new draft guidance titled “Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment,” a revision of a 2007 draft guidance with the same title.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 . . .
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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 . . .
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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 . . .
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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 . . .
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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 . . .
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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 . . .
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