Regulatory

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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.… Read more . . .