According to Alexza Pharmaceuticals, the company has submitted responses to the Day 120 List of Questions it received from the EMA's Committee for Medicinal Products for Human Use in March 2012 regarding its marketing application for Adasuve inhaled loxapine. The company says that it expects to receive a Day 180 List of Outstanding Issues for the MAA by the end of … [Read more...] about Alexza submits answers to Day 120 List of Questions for Adasuve
Regulatory
FDA issues form 483 to Exemplar (Updated)
The FDA has issued a 483 to Exemplar citing observations regarding problems with MDI filling from its March 21, 2012 inspection of the company's Massachusetts facility. Exemplar is referring inquiries about the issue to MAP Pharmaceuticals, which recently met with the FDA to address manufacturing problems with its Levadex inhaled dihydroergotamine cited in a Complete … [Read more...] about FDA issues form 483 to Exemplar (Updated)
FDA approves Asthmapolis inhaler sensor and app
The FDA has granted 510(k) clearance to Asthmapolis's asthma sensor system and mobile app. The sensor attaches to the top of an MDI canister, records data from an accelerometer and GPS receiver, and transmits the data wirelessly to a patient's smart phone. The device uses GPS data to record where and when the inhalers are used, providing information to public health … [Read more...] about FDA approves Asthmapolis inhaler sensor and app
European approval for flutiform
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
EPAG recommends further investigation of low volume cascade impaction for DPIs
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
CHMP issues positive recommendation for Seebri Breezhaler
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 resubmits Adasuve inhaled loxapine NDA
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
Pharmaxis submits NDA for Bronchitol, issues update on commercialization in Europe
Pharmaxis has submitted an NDA for Bronchitol inhaled dry powder mannitol for the treatment of cystic fibrosis to the FDA. Pharmaxis CEO Dr Alan Robertson said, “The submission marks the second of two key milestones for the Bronchitol program following approval last month to market the product in Europe. Cystic fibrosis patients have a life‐limiting disease. It … [Read more...] about Pharmaxis submits NDA for Bronchitol, issues update on commercialization in Europe
CHMP recommends approval of aclidinium for COPD in Europe
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
FDA approves generic version of Astelin nasal spray
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