Regulatory
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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.… Read more . . .
Upcoming Events
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA