Alexza Pharmaceuticals has received a EU Certificate of GMP Compliance of a Manufacturer subsequent to a May 2012 inspection by the Agencia Espanola de Medicamentos y Productos Sanitarios, the company has announced. Alexza plans to manufacture Adasuve Staccato loxapine at the facility in Mountain View, CA. Alexza says that the initial certificate will remain valid … [Read more...] about Alexza gets EU GMP certificate for Adasuve manufacturing facility
Regulatory
Symbicort Turbuhaler approved for COPD in Japan
Astellas and AstraZeneca have announced the approval of Symbicort Turbuhaler for COPD. The budesonide/formoterol fumarate DPI has been available for the treatment of asthma in Japan since January 2010. The two companies entered an agreement to co-promote Symbicort Turbuhaler in Japan in August 2009. According to the companies, "The approval of Symbicort … [Read more...] about Symbicort Turbuhaler approved for COPD in Japan
Health Canada to review calcitonin nasal spray risks
In the wake of the EMA's recent recommendation against use the use of calcitonin nasal sprays due to an increased risk of cancer, Health Canada says that it is also evaluating the risks of calcitonin products. Novartis, its generic division Sandoz, and Apotex market calcitonin nasal sprays in Canada. The agency, which says that it has not received any reports of … [Read more...] about Health Canada to review calcitonin nasal spray risks
Watson gets FDA approval for budesonide, sued over levalbuterol
The FDA has approved Watson Pharmaceuticals' Abbreviated New Drug Application (ANDA) for a generic version of Pulmicort Respules. The budesonide inhalation suspension 0.25mg/2mL and 0.5mg/2mL ampules are the subject of an ongoing patent dispute with AstraZeneca. Watson says that it if it prevails in court, it will launch the budesonide product by the end of this … [Read more...] about Watson gets FDA approval for budesonide, sued over levalbuterol
Health Canada issues advisory on potential Pulmicort Turbuhaler device failure
Health Canada has issued an advisory to health care professionals that "AstraZeneca Canada has received a small number of product complaints for Pulmicort Turbuhaler, 200 µg per metered dose (200 doses) regarding the malfunction of the delivery device that results in a failure to dispense the dose of medication." According to the notice, the devices sometimes fail to … [Read more...] about Health Canada issues advisory on potential Pulmicort Turbuhaler device failure
Unigene responds to EMA recommendation against use of calcitonin nasal spray
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
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