Regulatory
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Tonya Winders, President and CEO of Allergy & Asthma Network Mothers of Asthmatics (AANMA) will speak in opposition to the approval of Primatene HFA at the upcoming joint meeting of the FDA’s Nonprescription Drugs Advisory… Read more . . .
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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Anoro umeclidinium/vilanterol for the treatment of COPD, GlaxoSmithKline and Theravance have announced. The dosage would be 55 mcg/22… Read more . . .
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Sandoz has recently announced the approval of the AirFluSal Forspiro salmeterol/fluticasone DPI by Norway and Bulgaria, bringing the total number of European approvals to 7. The inhaler has also been approved in Denmark, Germany, Sweden,… Read more . . .
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Insmed has announced that the EMA’s Committee for Orphan Medicinal Products has issued a positive opinion regarding orphan designation for Insmed’s Arikace inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung disease. The… Read more . . .
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According to Avanir Pharmaceuticals, the company has submitted a 505(b)(2) New Drug Application (NDA) for its AVP-825 intranasal dry powder sumatriptan for the treatment of migraine to the FDA. Avanir acquired the North American license… Read more . . .
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Romania has approved the 50 µg/500 µg dose version of Sandoz’s AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD, triggering a €1.5 million milestone payment to Vectura. The inhaler has also been… Read more . . .
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Skyepharma has announced that Spain has completed a mutual recognition procedure regarding Flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of asthma. The European Commission approved Flutiform in July 2012. The company also said that… Read more . . .
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Sandoz has announced that it received marketing authorization for the AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD from Sweden and Hungary. The company’s version of Advair has also been approved by… Read more . . .
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Sandoz has received German marketing authorization for the AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD, the company has announced. The German approval is for the 50/500 µg version of the inhaler.… Read more . . .
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GlaxoSmithKline and Theravance have announced that Canadian regulators approved the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD on December 23, 2013, shortly after the US FDA approved the product. The dosage approved for… Read more . . .
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