FDA looks to regulate e-cigarettes

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, . . . Read more

Australia approves Breo Ellipta

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 medicine and making medicines available . . . Read more

Bayer ciprofloxacin DPI gets orphan drug status from the FDA

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 developing . . . Read more