Regulatory

The European Commission (EC) has approved SkyePharma's flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of asthma in the 21 European countries using the decentralized procedure. The CHMP issued a positive opinion for flutiform in April 2012 after the 21 member states had failed to reach a consensus in late 2011. The company says that it … [Read more...] about European approval for flutiform

A study by the European Pharmaceutical Aerosol Group (EPAG) titled "Effect of Sampling Volume on Dry Powder Inhaler (DPI)-Emitted Aerosol Aerodynamic Particle Size Distributions (APSDs) Measured by the Next-Generation Pharmaceutical Impactor (NGI) and the Andersen Eight-Stage Cascade Impactor (ACI)" and published on June 8, 2012 by AAPS PharmSciTech finds that reduced … [Read more...] about EPAG recommends further investigation of low volume cascade impaction for DPIs

According to Novartis, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Seebri Breezhaler glycopyrronium/NVA237 DPI for the treatment of COPD. Novartis submitted the MAA in September 2011. "This positive opinion for Seebri Breezhaler is a major milestone in our efforts to offer COPD patients and … [Read more...] about CHMP issues positive recommendation for Seebri Breezhaler

Alexza Pharmaceuticals says that it has resubmitted its NDA for Adasuve inhaled loxapine for the treatment of agitation in patients with bipolar disorder or schizophrenia; the company received a Complete Response Letter for the Adasuve NDA in May 2012. The company says that it expects a response from the FDA as to how the resubmission will be classified and the new … [Read more...] about Alexza resubmits Adasuve inhaled loxapine NDA

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for approval of Almirall's Eklira Genuair aclidinium DPI for the treatment of COPD. The Genuair inhaler is a proprietary multidose, cartridge-based dry powder inhaler. Almirall Chief Scientific Officer Bertil Lindmark commented,”The … [Read more...] about CHMP recommends approval of aclidinium for COPD in Europe

According to Sun Pharma, the FDA has approved an Abbreviated New Drug Application (ANDA) for a generic version of azelastine nasal spray submitted by a Sun subsidiary. Sun notes that the US sales of azelastine nasal spray are about $144 million annually. Astelin and Astepro azelastine sprays are distributed in the US by Meda. Astepro is a newer formulation … [Read more...] about FDA approves generic version of Astelin nasal spray

According to Insmed, the FDA has lifted the clinical hold placed on Arikace liposomal amikacin for inhalation for the treatment of pseudomonas lung infections in cystic fibrosis patients in July 2011. A hold on Arikace for non-tuberculous mycobacteria (NTM) lung disease was lifted in January of this year. Insmed says that it has reached an agreement with the FDA … [Read more...] about FDA lifts clinical hold on Arikace inhaled liposomal amikacin

The FDA has issued a complete response letter to Alexza Pharmaceuticals regarding its New Drug Application (NDA) for Adasuve loxapine inhalation powder for the treatment of agitation associated with schizophrenia or bipolar I disorder in adults. The FDA had previously extended the review period after Alexza submitted an updated proposed Risk Evaluation and Mitigation … [Read more...] about Alexza gets complete response letter for Adasuve

According to Meda, the FDA has approved Meda's Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis. Meda filed the NDA approximately one year ago, in April 2011. Meda CEO Anders Lonner said, "Allergic rhinitis is an increasing problem. Many patients have severe symptoms that cause inability to work … [Read more...] about FDA approves Meda’s Dymista nasal spray, warns company on Astepro script