Regulatory

An effort to return remaining units of Primatene Mist epinephrine inhalers to the market failed in the US House of Representatives on December 12, 2012 by a vote of 229-182. Primatene Mist, a CFC-propelled MDI manufactured by Amphastar Pharmaceuticals, was the only over the counter asthma inhaler available in the US until it was removed from the market in accordance … [Read more...] about “Asthma Inhalers Relief Act of 2012” fails in US House of Representatives

Maryland-based CRO Next Breath, which specializes in OINDP analysis, has announced that an October 15, 2012 GMP inspection by the FDA found the company's Baltimore facility to be compliant. The inspection resulted in no Form 483 and no observations. Earlier this year, the World Health Organization (WHO) accredited Next Breath as a testing facility for nasal spray … [Read more...] about Next Breath announces successful FDA inspection

According to Savara Pharmaceuticals, the company's AeroVanc inhaled vancomycin for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis patients has been granted orphan drug status by the FDA. Aerovanc inhalation powder, which is delivered using a capsule-based DPI, has completed Phase 1 trials, and Savara says that it is … [Read more...] about Savara’s AeroVanc gets orphan drug designation in US

QVA149 developers Vectura and Sosei have confirmed that Novartis has submitted an application for Japanese approval of the inhaled fixed dose combination of indacaterol maleate and glycopyrronium bromide for the treatment of COPD. Novartis, which licensed the DPI from the two companies, also recently submitted an application for the product in Europe. Japan … [Read more...] about Novartis files application for QVA149 in Japan

Pharmaxis's Bronchitol mannitol dry powder for inhalation has become the first treatment for cystic fibrosis to receive a positive recommendation from he UK National Institute for Health and Clinical Excellence (NICE), according to the company. The recommendation allows for reimbursement by the National Health Service. Pharmaxis CEO Alan Robertson commented, … [Read more...] about NICE approves Bronchitol inhalation powder for CF

Novartis has filed a marketing application with the EMA for its QVA149 indacaterol maleate/glycopyrronium bromide DPI for the treatment of COPD. The filing triggered milestone payments of $5 million each to the drug's developers, Vectura and Sosei. Vectura Chief Executive Chris Blackwell, “The IGNITE program is among the largest COPD clinical trial programs … [Read more...] about Novartis files MAA for QVA149

MAP Pharmaceuticals has resubmitted its New Drug Application (NDA) for Levadex inhaled dihydroergotamine for the treatment of migraine to the FDA, the company has announced. The FDA issued a complete response letter to MAP in March, 2012 and a form 483 to its contract manufacturer. MAP President and CEO Timothy S. Nelson said, "We have worked diligently on our … [Read more...] about MAP resubmits Levadex NDA

As expected, the European Commission has approved Novartis's Seebri Breezhaler glycopyrronium bromide DPI for the treatment of COPD. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for glycopyrronium in June 2012. The announcement comes just days after the announcement of the approval of Seebri … [Read more...] about EC approves Seebri Breezhaler

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Novartis's Seebri glycopyrronium bromide inhalation capsules, delivered by the Breezhaler DPI, for the treatment of COPD. The product should be available in Japan by the end of 2012. The glycopyrronium inhalation formulation was co-developed by Sosei and Vectura, which licensed it to Novartis … [Read more...] about Seebri inhalation capsules approved in Japan