Regulatory

Sandoz has recently announced the approval of the AirFluSal Forspiro salmeterol/fluticasone DPI by Norway and Bulgaria, bringing the total number of European approvals to 7. The inhaler has also been approved in Denmark, Germany, Sweden, Hungary, and Romania. The Norwegian approval is for the 50/250 µg and 50/500 µg dosages for the treatment of asthma and for … [Read more...] about AirFluSal Forspiro approved in additional countries

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 company says that it plans to report top line results from a Phase 2 trial of Arikace for NTM lung disease by the … [Read more...] about Arikace to get orphan drug designation from EU

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 for the product from OptiNose in July 2013. The product uses OptiNose's delivery device, which uses the patient's breath to … [Read more...] about Avanir submits NDA for dry powder intranasal sumatriptan

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 approved recently by Denmark, Germany, Sweden, and Hungary. Read the Sandoz press release. … [Read more...] about Romania approves AirFluSal Forspiro

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 its European partner Mundipharma plans to launch the product in Spain after pricing and reimbursement have … [Read more...] about Spain moving toward Flutiform approval

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