Regulatory

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

The FDA has granted orphan drug designation to a ciprofloxacin DPI being developed by Bayer HealthCare for the treatment of non-cystic fibrosis bronchiectasis, the company has announced. The dry powder formulation, based on Novartis's PulmoSphere platform, is delivered using the T-326 (Podhaler) DPI. The product is currently in Phase 3 trials. Bayer is also … [Read more...] about Bayer ciprofloxacin DPI gets orphan drug status from the FDA

Canada has approved GSK's Incruse Ellipta umeclidinium (UMEC) DPI for the once-daily treatment of COPD, the first approval for its UMEC monotherapy, the company said. GSK received a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) regarding its MAA for Incruse Ellipta in February 2014, and the company submitted an NDA for the … [Read more...] about Incruse Ellipta approved in Canada

The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for MannKind's Afrezza inhaled insulin by three months, according to MannKind. The original date was April 15, 2014; the new date is July 15, 2014. The agency's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended approval of Afrezza on April 2, 2014. The delay was … [Read more...] about PDUFA date for Afrezza now July 15, 2014

On April 2, 2014, the FDA issued a draft guidance for fentanyl citrate nasal spray. The guidance offers an in vitro option, saying, "If the test product is qualitatively (Q1) and quantitatively (Q2) the same as the reference product, then bioequivalence may be documented by an in vitro approach in lieu of an in vivo approach." If bioequivalence cannot be … [Read more...] about FDA issues draft guidance for fentanyl citrate nasal spray