Regulatory

Skyepharma has announced that Spain has completed a mutual recognition procedure regarding Flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of asthma. The European Commission approved Flutiform in July 2012. The company also said that… Read more . . .

Sandoz has received German marketing authorization for the AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD, the company has announced. The German approval is for the 50/500 µg version of the inhaler.… Read more . . .

GlaxoSmithKline and Theravance have announced that Canadian regulators approved the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD on December 23, 2013, shortly after the US FDA approved the product. The dosage approved for… Read more . . .

MannKind Corporation has announced that a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee for a review of the company’s NDA for Afrezza insulin inhalation powder has been scheduled tentatively for April 1,… Read more . . .

The FDA’s Nonprescription Drugs Advisory Committee and Pulmonary Allergy Drugs Advisory Committee (PADAC) will meet on February 25, 2014 to consider a new drug application submitted by Armstrong Pharmaceuticals for an OTC epinephrine inhalation aerosol… Read more . . .

Daiichi Sankyo has announced that Japanese regulators have approved its Inavir laninamivir octanoate hydrate DPI for the prevention of the flu. In August 2012, the company had announced positive Phase 3 results for that indication.… Read more . . .

Sandoz has received Danish marketing authorization for the AirFluSal Forspiro inhaler for the treatment of asthma and/or COPD in 50-250µg and 50-500µg versions. Sandoz acquired European rights to the product (formerly known as VR-315) from… Read more . . .

The FDA has announced the approval of GSK and Theravance’s Anoro Ellipta umeclidinium/vilanterol inhalation powder for the treatment of COPD. The approval triggers a $30 million milestone payment from Theravance to GSK. Theravance will pay… Read more . . .

FLUIDDA has announced that it will meet with the FDA on January 17, 2014 to present its Functional Respiratory Imaging (FRI) technology for screening respiratory drugs. The FDA is evaluating FRI as part of its… Read more . . .