Regulatory
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GSK’s Veramyst fluticasone furoate nasal spray will soon be available as an over-the-counter product marketed as Flonase Sensimist, GSK Consumer Healthcare has announced. According to the company, the FDA has approved Flonase Sensimist as an… Read more . . .
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Sunovion has submitted a new drug application to the FDA for its SUN-101/eFlow glycopyrrolate for the treatment of COPD, the company said. The company recently reported positive results from the GOLDEN-5 long-term safety study of… Read more . . .
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The FDA has approved St. Renatus’s Kovanaze tetracaine HCl and oxymetazoline HCl nasal spray, the company announced. The product is approved for regional anesthesia for adults and children weighing 40 kg or more who are… Read more . . .
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While Health Canada conducts an expedited review of a new drug submission (NDS) for naloxone nasal spray, Minister of Health Jane Philpott has signed an Interim Order temporarily allowing naloxone nasal spray imported from the… Read more . . .
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The FDA has made the approval packages for Boehringer Ingelheim’s Stiolto Respimat and Spiriva Respimat available on its website. The Stiolto Respimat tiotropium bromide/olodaterol SMI, which is marketed as Spiolto Respimat in Europe, was approved… Read more . . .
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Teva has announced the FDA’s acceptance of the company’s NDAs for fluticasone propionate (FP)/salmeterol and FP monotherapy DPIs for the treatment of asthma. Both products are delivered using the breath-activated RespiClick inhaler. In late 2015,… Read more . . .
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The Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) has recommended against the use of MedImmune’s FluMist Quadrivalent Live Attenuated Influenza Vaccine (FluMist Quadrivalent) for the 2016-2017… Read more . . .
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GlaxoSmithKline and Innoviva have presented data from the FULFIL study of its fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI versus Symbicort for COPD, reiterating that the data support the company’s plans to file an NDA for the product… Read more . . .
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Insmed has announced the withdrawal of its marketing authorization application for Arikayce inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung disease. The MAA was submitted to the European Medicines Agency in 2014,… Read more . . .
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Chiesi says that it is on track with planned regulatory submissions in the EU for its ICS/LAMA/LABA MDI for the treatment of COPD by the end of 2016 after successful completion of two 12-month Phase… Read more . . .
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