Regulatory

Insmed has announced that the EMA’s Committee for Orphan Medicinal Products has issued a positive opinion regarding orphan designation for Insmed’s Arikace inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung disease. The… Read more . . .

According to Avanir Pharmaceuticals, the company has submitted a 505(b)(2) New Drug Application (NDA) for its AVP-825 intranasal dry powder sumatriptan for the treatment of migraine to the FDA. Avanir acquired the North American license… Read more . . .

Romania has approved the 50 µg/500 µg dose version of Sandoz’s AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD, triggering a €1.5 million milestone payment to Vectura. The inhaler has also been… Read more . . .

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 . . .