Regulatory

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

The European Commission (EC) has approved MedImmune's Fluenz Tetra intranasal four-strain live attenuated influenza vaccine for the prevention of flu in children aged 24 months to 18 years, parent company AstraZeneca has announced. Fluenz Tetra includes two strains of influenza A and two strains of influenza B; previous vaccines have contained only one strain of … [Read more...] about Fluenz Tetra approved in Europe for the prevention of flu in children

Taiwan's FDA has canceled marketing authorizations for calcitonin nasal sprays effective December 1 2013, and the products must be recalled within two months. According to the China Post, calcitonin nasal spray was first licensed in Taiwan in 1990. The Taiwan FDA is the latest regulatory agency to act on concerns about cancer risks posed by calcitonin nasal … [Read more...] about Taiwan FDA withdraws marketing authorization for calcitonin nasal spray

GSK and Theravance have announced that the European Commission has approved Relvar Ellipta fluticasone furoate/vilanterol (FF/VI) DPI for the treatment of asthma for patients whose disease is not adequately controlled by ICS plus an as-needed SABA and for COPD where patients do not have adequate control with regular bronchodilator use. Relvar has been approved in … [Read more...] about Relvar Ellipta approved in EU