Regulatory

The FDA draft guidance on albuterol sulfate MDIs published April 8, 2013 includes recommendations for a total of 7 studies, including 5 in vitro studies, 1 PK study, and 1 PD study to establish bioequivalence.… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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 . . .