Unigene Laboratories, which manufactures Fortical calcitonin nasal spray for the treatment of osteoporosis, has requested product safety data submitted to the EMA's Committee for Medicinal Products for Human Use (CHMP) in response to the EMA's recommendation against use of calcitonin nasal sprays. The EMA report, issued on July 19, 2012, notes a 2.4% increase in the … [Read more...] about Unigene responds to EMA recommendation against use of calcitonin nasal spray
Regulatory
Eklira/Bretaris Genuair aclidinium bromide DPI gets approval in Europe
Just after announcing the approval of the Tudorza Pressair aclidinium bromide dry powder inhaler for the treatment of COPD in the US, Almirall has announced that the European Commission has granted marketing approval to its aclidinium DPI, which will be marketed as the Eklira or Bretaris Genuair in Europe. The approval applies to all EU member states, Iceland and … [Read more...] about Eklira/Bretaris Genuair aclidinium bromide DPI gets approval in Europe
“Asthma Inhalers Relief Act of 2012” aims to allow sales of remaining CFC inhalers
The US House of Representatives held a meeting on July 18, 2012 regarding the "Asthma Inhalers Relief Act of 2012," which is intended "To direct the Administrator of the Environmental Protection Agency to allow for the distribution, sale, and consumption in the United States of remaining inventories of over-the-counter CFC epinephrine inhalers." Witnesses who … [Read more...] about “Asthma Inhalers Relief Act of 2012” aims to allow sales of remaining CFC inhalers
FDA approves Tudorza Pressair aclidinium bromide DPI
The FDA has approved the Tudorza Pressair aclidinium bromide dry powder inhaler for the treatment of COPD. The DPI will be distributed by Forest Pharmaceuticals, a division of Forest Laboratories, which licensed US rights to the product from Almirall. Forest says that it expects wholesalers to have the product in the fourth quarter of 2012. Almirall President Jorge … [Read more...] about FDA approves Tudorza Pressair aclidinium bromide DPI
Alexza submits answers to Day 120 List of Questions for Adasuve
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
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