Regulatory

According to an FDA spokesperson, the FDA Nonprescription Drugs Advisory Committee (NDAC) and Pulmonary Allergy Drugs Advisory Committee (PADAC) voted not to support approval of Armstrong Pharmaceuticals' NDA for Primatene HFA during a joint meeting on February 25, 2014. Armstrong is seeking to market the epinephrine MDI over the counter for the treatment of … [Read more...] about FDA advisory committees vote against recommending approval of Primatene HFA

Shortly after announcing that the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding Anoro umeclidinium/vilanterol, GSK has announced that CHMP also issued a positive opinion regarding umeclidinium monotherapy. According to GSK, the product would be marketed as "Incruse" and would deliver a 55 mcg dose of UMEC via the … [Read more...] about Positive opinion from CHMP for umeclidinium monotherapy

According to Teva, the company's DuoResp Spiromax budesonide/formoterol fumarate inhalation powder has received a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP). The company has applied to market the product in Europe for the treatment of asthma and COPD. Teva President of Global R&D and Chief Scientific Officer Michael … [Read more...] about Teva gets positive opinion from CHMP for DuoResp Spiromax

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Anoro umeclidinium/vilanterol for the treatment of COPD, GlaxoSmithKline and Theravance have announced. The dosage would be 55 mcg/22 mcg UMEC/VI, delivered by the Ellipta DPI. Anoro Ellipta was approved in the US in December 2013 and in Canada in … [Read more...] about CHMP issues positive opinion for Anoro

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