Regulatory
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The British Pharmacopoeia (BP) Inhaled Products Working Party has published its recommendations for BP monographs for inhalation as of September 17, 2012. According to the document, “Safety and efficacy are critical considerations; the Working Party… Read more . . .
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GlaxoSmithKline says that it submitted a Japanese New Drug Application (JNDA) for its fluticasone furoate (FF)/vilanterol(VI) dry powder inhaler for the treatment of COPD and asthma on September 25, 2012. The FF/VI combination will be… Read more . . .
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Acton Pharmaceuticals has announced plans to launch its Aerospan flunisolide HFA metered dose inhaler in early 2013 after having received FDA approval for the MDI. The product is approved for for the maintenance treatment of… Read more . . .
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The FDA has approved InnoPharma’s ANDA for acetylcysteine solution. The New Jersey company has a deal with Fresenius Kabi USA to market acetylcysteine solution in the US, where there has been a shortage of the… Read more . . .
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The Anti-Infective Drugs Advisory Committee (AIDAC) of the FDA voted 13 to 1 in favor of approval of Novartis’s tobramycin inhalation powder (TIP) for the treatment of P. aeruginosa-infected cystic fibrosis patients six years old… Read more . . .
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The FDA briefing materials for the September 5, 2012 meeting of the Anti-Infective Drugs Advisory Committee, which will consider the use of Novartis’s Tobi tobramycin inhalation powder (TIP) for the treatment of P. aeruginosa infections… Read more . . .
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According to Novartis, the latest Phase 3 study of the QVA149 indacaterol/glycopyrronium DPI demonstrated a significant reduction in exacerbations of moderate-to-severe COPD compared to the Seebri Breezhaler glycopyrronium bromide DPI alone. The company says that… Read more . . .
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GlaxoSmithKline says that it will begin regulatory submissions for its umeclidinium bromide (UMEC) and vilanterol (VI) dry powder inhaler for the treatment of COPD by the end of 2012. GSK is partnered with Theravance on… Read more . . .
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Alexza Pharmaceuticals has received a EU Certificate of GMP Compliance of a Manufacturer subsequent to a May 2012 inspection by the Agencia Espanola de Medicamentos y Productos Sanitarios, the company has announced. Alexza plans to… Read more . . .
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Astellas and AstraZeneca have announced the approval of Symbicort Turbuhaler for COPD. The budesonide/formoterol fumarate DPI has been available for the treatment of asthma in Japan since January 2010. The two companies entered an agreement… Read more . . .
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