Regulatory

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. Denmark approved both the 50/250 µg and 50/500 µg versions of the product in December 2013. The German authorization triggers a $2 … [Read more...] about AirFluSal Forspiro gets German market authorization

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 Canada is 62.5/25mcg. GSK Canada President Paul Lirette commented, “The market authorization of Anoro Ellipta in Canada … [Read more...] about Anoro Ellipta approved in Canada

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, 2014. The FDA set a PDUFA date of April 15, 2014 for Afrezza after MannKind resubmitted its NDA for the product in October 2013. … [Read more...] about FDA committee review of Afrezza tentatively set for April 1

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 for the treatment of mild asthma. Armstrong, which is owned by Amphastar, marketed the Primatene Mist OTC epinephrine … [Read more...] about FDA advisory committees to discuss Primatene HFA

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. The inhaler was approved for treatment of the flu in Japan in October 2010. The company said that it "has great expectations for the … [Read more...] about Japan approves Inavir DPI for prevention of flu

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 Vectura in 2006 and for the rest of the world except the US in 2011. Sandoz Global Head Jeff George commented, “The first … [Read more...] about Denmark approves generic fluticasone/salmeterol DPI

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 another $30 million on launch, which is expected to take place in the first quarter of 2014. GSK and Theravance submitted an … [Read more...] about FDA approves Anoro Ellipta

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 critical path initiative, which includes the development of new biomarkers. The technology combines CT scans with flow simulations, creating patient-specific … [Read more...] about FLUIDDA to present Functional Respiratory Imaging technology to FDA

Savara Pharmaceuticals has announced that its AeroVanc inhaled vancomycin has received Fast Track designation from the FDA and been designated as a Qualified Infectious Disease Product (QIDP) for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis patients. According to the company, the new designations will result in … [Read more...] about AeroVanc gets Fast Track and QIDP designations from FDA