Regulatory

According to Insmed Incorporated, the US FDA has granted orphan drug designation to its Arikace liposomal amikacin for inhalation for the treatment of non-tuberculous mycobacteria (NTM) infections. Insmed is also developing Arikace for the treatment of P. aeruginosa infections in cystic fibrosis patients. The company also has announced the appointment of Matthew Pauls … [Read more...] about Insmed gets orphan drug designation for Arikace, appoints new chief commercial officer

The UK's National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending Novartis's Tobi Podhaler tobramycin DPI and Forest Lab's Colobreathe colistimethate sodium DPI for the treatment of P. aeruginosa lung infections in cystic fibrosis patients when patients are unable to use other treatments. In January 2013, NICE issued a final … [Read more...] about NICE issues final guidance on Tobi Podhaler and Colobreathe for some CF patients

According to the EMA, its Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion regarding the Labazenit budesonide/salmeterol dry powder inhaler. Belgian pharmaceutical company Laboratoires SMB applied to market the product, which is delivered using its Axahaler DPI device, for the treatment of asthma in adults. The CHMP expressed … [Read more...] about CHMP adopts negative opinion on Labazenit

The FDA has approved Novartis's TOBI Podhaler tobramycin inhalation powder for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. The agency's Anti-Infective Drugs Advisory Committee (AIDAC) voted in favor of approval of the dry powder inhaler in September 2012. According to Novartis, the product will be available in the second quarter of … [Read more...] about FDA approves TOBI Podhaler

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