Regulatory

The Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting regarding Breo Ellipta originally scheduled for March 7, 2013 has been rescheduled for April 17, 2013, from 8 am to 5 pm. The meeting was rescheduled due to weather concerns. The purpose of the meeting is to discuss GSK's new drug application for its fluticasone furoate/vilanterol dry powder inhaler. … [Read more...] about PADAC meeting on Breo Ellipta rescheduled

According to Pharmaxis, the FDA has issued a complete response letter regarding its Bronchitol inhaled mannitol for the treatment of cystic fibrosis. The company says that the FDA requested another clinical trial. The Pharmaxis press release quotes the CRL, which says, “The submitted data do not provide a favorable benefit‐risk balance to support the use of inhaled … [Read more...] about Pharmaxis gets complete response letter for Bronchitol

According to Mylan, its subsidiary Mylan Specialty L.P. has received FDA approval for its Abbreviated New Drug Application (ANDA) for levalbuterol inhalation solution, a generic version of Sunovion's Xopenex inhalation solution. The product is used for the treatment of bronchospasm caused by asthma and COPD. Mylan says that it has begun shipping product. Sunovion … [Read more...] about Mylan levalbuterol inhalation solution ANDA approved

In a joint meeting of the FDA's Advisory Committee for Reproductive Health Drugs (ACRHD) and the Drug Safety and Risk Management Advisory Committee (DSaRM), panelists voted 12-9 that the risk of cancer from calcitonin outweigh its potential benefits for osteoporosis. The panel also voted 20-1 that developers of new calcitonin products would have to prove efficacy in … [Read more...] about FDA panel votes against calcitonin nasal spray

The March 7 meeting of the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) for discussion of the Breo Ellipta inhaler, has been postponed due to weather. As of March 6, the meeting on GSK's application for the fluticasone furoate/vilanterol dry powder inhaler has not been rescheduled. Read the meeting announcement. … [Read more...] about PADAC meeting on Breo Ellipta postponed

According to Marinomed, the company's Coldamaris anti-virus nasal spray has been approved in Canada as a "natural health product." The over-the-counter product has been registered in Europe, where it is licensed to Boehringer Ingelheim, since 2007. Coldamaris, which contains a red algae extract called Carragelose, is approved in 38 countries as a prophylactic and … [Read more...] about Marinomed gets Canadian approval for anti-virus nasal spray

According to GSK and Theravance, the FDA has accepted their NDA for the Anoro Ellipta umeclidinium bromide (UMEC)/vilanterol (VI) dry powder inhaler for the treatment of COPD, with a PDUFA date of December 18, 2013. The two companies submitted the NDA in December 2012. GSK and Theravance also submitted an MAA for Anoro earlier this year, and that application has … [Read more...] about FDA accepts NDA for Anoro Ellipta DPI

The FDA and the US Federal Trade Commission (FTC) have issued a warning to a Florida company called Flu and Cold Defense LLC regarding its claims for an over-the-counter nasal vapor inhalation product called GermBullet. The warning cites claims such as, "[GermBullet] has been laboratory tested and shown to reduce illness-causing bacteria, cold and flu viruses and … [Read more...] about FDA issues warning to company for unapproved inhaler