Regulatory

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 for the treatment of seasonal and perennial allergic rhinitis in patients 12 and older in March 2012. Teva Senior VP Global Respiratory … [Read more...] about FDA accepts Teva’s supplemental application for pediatric QNASL

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 a positive opinion regarding Anoro in February 2014. The approval triggers a $15 million milestone payment from … [Read more...] about Anoro Ellipta approved in Europe

Propeller Health (formerly known as Asthmapolis) has announced that the latest version of its inhaler tracking system has received 510(k) clearance from the FDA. The system includes a sensor that snaps onto an MDI and mobile apps that monitor and analyze inhaler use. According to Propeller, the newly approved system also predicts asthma and COPD exacerbations and … [Read more...] about FDA approves Propeller Health’s latest inhaler tracking system

The FDA has issued a Complete Response Letter (CRL) for Acorda Therapeutics' Plumiaz diazepam nasal spray for the treatment of cluster seizures in epilepsy patients, the company has announced. Acorda submitted a 505(b)(2) application for the product in November 2013. The company acquired the product along with its developer Neuronex in 2012. The CRL means that the … [Read more...] about Acorda gets Complete Response Letter for Plumiaz diazepam nasal spray

Less than a week after the approval of GSK's Incruse Ellipta umeclidinium DPI in Europe, the company has announced that the FDA has approved the product for the treatment of COPD and it expects to launch Incruse Ellipta in the US by the end of the year. GSK submitted the NDA for umeclidinium monotheraphy at the end of April 2013. GSK Global Respiratory Franchise … [Read more...] about FDA approves Incruse Ellipta for COPD

GSK has announced that the European Commission has granted marketing authorization for its Incruse Ellipta umeclidinium DPI for the treatment of COPD with a dosage of 55 mcg. According to the company's announcement, launches in several European countries are anticipated by the end of the year. GSK Global Respiratory Franchise Senior VP and Head Darrell Baker … [Read more...] about Incruse Ellipta approved in Europe

The European Commission has approved Teva's DuoResp Spiromax budesonide/formoterol DPI for the treatment of asthma and COPD, the company has announced. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the DuoResp Spiromax application in February 2014. Teva Global Specialty Medicines President and CEO Rob Koremans … [Read more...] about Teva gets European marketing authorization for DuoResp Spiromax

The US FDA has proposed a new rule that would require e-cigarette makers to register with the agency, disclose ingredients used in their inhalation solutions, and provide scientific evidence to support claims of reduced risk for their products. The rule would also require health warnings and add minimum age requirements for sales. In February 2011, the US Supreme … [Read more...] about FDA looks to regulate e-cigarettes

Australia's Therapeutic Goods Administration (TGA) has approved the Breo Ellipta fluticasone furoate/vilanterol for the treatment of asthma and COPD, according to GSK Australia and Theravance. GSK Medical Director Andrew Yeates commented, “We are delighted that Breo Ellipta is now approved in Australia. GSK is committed to supporting innovation in respiratory … [Read more...] about Australia approves Breo Ellipta