Regulatory
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According to Smartinhaler manufacturer Nexus6, the FDA has granted 510(k) marketing clearance for a new version of the inhaler monitoring system called SmartTouch. The system includes a touch screen on the monitoring device and is… Read more . . .
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According to Trimel Pharmaceuticals, the FDA has approved its Natesto nasal testosterone for men with low levels of endogenous testosterone. Trimel submitted an NDA for the product, then called CompleoTRT, in April 2013. Trimel President… Read more . . .
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The FDA has approved Teva’s QVAR beclomethasone HFA metered dose inhaler with a dose counter for the treatment of asthma, and the company plans to launch the product later in 2014, Teva said. Teva Global… Read more . . .
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GlaxoSmithKline has submitted an NDA for its umeclidinium (UMEC) Ellipta DPI for the treatment of COPD to the Japanese Ministry of Health, Labour and Welfare, the company announced. The product was approved under the name… Read more . . .
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Aradigm has announced that the FDA has designated its Pulmaquin inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis patients as a Qualified Infectious Disease Product (QIDP). QIDP status makes the… Read more . . .
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As part of an interim management statement, Skyepharma has said that the launch of its Flutiform fluticasone/formoterol MDI in Spain could take place by the end of 2014, triggering a milestone payment of €2.0 million.… Read more . . .
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Apotex says that it launched a generic budesonide nasal spray in the US on May 13, 2014 following the previous day’s approval of the product by the FDA. The new product, with a strength of… Read more . . .
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Teva has announced the FDA’s acceptance of its supplemental NDA for a low-dose formulation of QNASL beclomethasone dipropionate HFA nasal spray for the treatment of allergic rhinitis in children aged 4-11. The FDA approved QNASL… Read more . . .
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Perrigo has announced that it has begun shipping its generic version of Astepro azelastine nasal spray after the ANDA it submitted in partnership with Impax Laboratories received final approval from the FDA. In January 2012,… Read more . . .
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GlaxoSmithKline and Theravance have announced that they have received marketing authorization for the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD in Europe. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issues… Read more . . .
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October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA