Regulatory
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According to Adherium, the FDA has okayed over-the-counter (OTC) sales of the company’s Smartinhaler sensor for AstraZeneca’s Symbicort MDI. The 510(k) OTC clearance will allow patients to purchase the sensor without a prescription at local… Read more . . .
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Acorda Therapeutics has submitted a marketing authorization application to the EMA for its Inbrija levodopa DPI for the treatment of OFF periods in Parkinson’s disease patients, the company said. The application is supported by data… Read more . . .
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Orion Corporation has announced that its salmeterol/fluticasone Easyhaler combination DPI has received a positive opinion under the EU’s decentralized procedure, with Sweden as the reference member state. Orion had announced in December 2016 that it… Read more . . .
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According to Hikma Pharmaceuticals, the FDA has concluded the dispute resolution process regarding HIkma’s ANDA for its generic version of the Advair fluticasone propionate/salmeterol DPI and has requested a new clinical study. The FDA issued… Read more . . .
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Aradigm has submitted a marketing authorization application to the EMA for Linhaliq dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the company said. In… Read more . . .
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A Type II variation application for the use of the Relvar Ellipta fluticasone furoate/vilanterol DPI in patients whose asthma is adequately controlled by an ICS/LABA combination has been approved by the EC, according to GSK… Read more . . .
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Less than a week after GSK Canada said that it had recalled a lot of Ventolin Diskus in Canada due to “a manufacturing issue that may result in a small number of Ventolin Diskus devices… Read more . . .
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AstraZeneca has announced that the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has voted to recommend the use of FluMist Quadrivalent intranasal live Influenza vaccine for the 2018-19 flu… Read more . . .
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The US Patent and Trademark Office has issued US Patent Number 9,895,385, titled “Methods for treating pulmonary non-tuberculous mycobacterial infections” to Insmed Incorporated, the company said. According to Insmed, the patent is the 9th for… Read more . . .
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The FDA has accepted Acorda Therapeutics’ revised NDA for Inbrija inhaled levodopa for the treatment of symptoms associated with OFF periods in Parkinson’s disease in patients taking carbidopa/levodopa, the company said. The PDUFA target date… Read more . . .
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