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Regulatory

Airflusal Forspiro approved in Mexico

Sandoz has announced that the Mexican health authority, COFEPRIS, has approved the company's marketing application for the Airflusal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and for COPD. Three dosage levels were approved: 50-100 µg, 50-250 µg and 50-500 µg. The product will be marketed as IrFlosol Forspiro in Mexico. The Mexican approval … [Read more...] about Airflusal Forspiro approved in Mexico

FDA approves GSK’s fluticasone furoate DPI, Arnuity Ellipta

GlaxoSmithKline has announced that it has received FDA approval for its fluticasone furoate DPI, to be marketed as Arnuity Ellipta, for the maintenance treatment of asthma. The approval is for 100mcg and 200mcg doses and for patients age 12 and older. GSK submitted the NDA for Arnuity Ellipta in October 2013. GSK Senior VP and Head, GSK Global Respiratory … [Read more...] about FDA approves GSK’s fluticasone furoate DPI, Arnuity Ellipta

Boehringer Ingelheim files NDA for tiotropium/olodaterol Respimat

The FDA has accepted Boehringer Ingelheim's New Drug Application for its tiotropium/olodaterol Respimat soft mist inhaler for the treatment of COPD, the company has announced. BI's Striverdi Respimat olodaterol SMI was approved by the FDA at the end of July 2014, and the agency's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recently voted in favor of … [Read more...] about Boehringer Ingelheim files NDA for tiotropium/olodaterol Respimat

FDA advisory committee votes for approval of Spiriva Respimat

The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 10-3 to approve Boehringer Ingelheim's Spiriva Respimat tiotropium soft mist inhaler for the treatment of COPD. BI's first NDA submission for tiotropium Respimat took place in 2007. Numerous safety questions about tiotropium have been raised over the years, and a briefing document for the PADAC … [Read more...] about FDA advisory committee votes for approval of Spiriva Respimat

Insmed to proceed with Phase 3 study of Arikayce, will file MAA in 2014

Insmed has announced that it will move ahead with a Phase 3 trial of Arikayce inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung infections, with results expected in 2017. According to the company, it met with the FDA regarding the study, and "the FDA acknowledged that exploration of the effectiveness of Arikayce in a broader … [Read more...] about Insmed to proceed with Phase 3 study of Arikayce, will file MAA in 2014

Striverdi Respimat approved by the FDA

The FDA has announced the approval of Boehringer Ingelheim's Striverdi Respimat olodaterol SMI for the treatment of COPD. The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended approval of Striverdi Respimat in January 2013. The soft mist inhaler was approved in the EU in October 2013. Curtis Rosebraugh, Director of the Office of Drug Evaluation … [Read more...] about Striverdi Respimat approved by the FDA

FDA approves Flonase for over the counter sales

GlaxoSmithKline has announced that the FDA has approved its Flonase fluticasone propionate nasal spray for the treatment of allergic rhinitis for over-the-counter sale. The approval is for a 50 mcg spray, the same as the current prescription strength. According to GSK, Flonase Allergy Relief will be available over the counter in the US in early 2015. GSK … [Read more...] about FDA approves Flonase for over the counter sales

Lightlake files IND for intranasal naloxone, gets additional NIDA funding

Lightlake Therapeutics has announced that it filed an investigational new drug application for its intranasal naloxone therapy for the reversal of opioid overdose. The company also said that it has received additional funding from the National Institute on Drug Abuse (NIDA) for a new clinical trial of the product. Lightlake recently said that it had signed a … [Read more...] about Lightlake files IND for intranasal naloxone, gets additional NIDA funding

Incruse Ellipta approved in Australia

GlaxoSmithKline has announced that the Australian Therapeutic Goods Administration (TGA) has approved the Incruse Ellipta umeclidinium DPI for the treatment of COPD. Incruse Ellipta was approved in Canada and in Europe in April 2014 and in the US in May 2014. GSK Associate Medical Director Navin Singh said, “We are delighted by the TGA approval of Incruse … [Read more...] about Incruse Ellipta approved in Australia

AntiOp gets FDA Fast Track designation for its naloxone nasal spray

According to Kentucky-based AntiOp, the company has received Fast Track designation from the FDA for its intranasal naloxone for the reversal of opioid overdose. The company is co-developing the unit-dose nasal spray, its only product, with Reckitt Benckiser and has received approximately $4.5 million in grant funding from the National Institutes of Health and its … [Read more...] about AntiOp gets FDA Fast Track designation for its naloxone nasal spray

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