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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

Quintiles to promote Almirall respiratory products in UK, beginning with Eklira Genuair

Quintiles will promote respiratory drugs from Almirall in the UK, starting with the newly approved Eklira Genuair aclidinium bromide dry powder inhaler for the treatment of COPD. Quintiles performed some of the clinical study work for the product. Menarini will market the DPI in most of Europe as Bretaris Genuair. Almirall UK General Manager Carlos Gallardo … [Read more...] about Quintiles to promote Almirall respiratory products in UK, beginning with Eklira Genuair

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

All UK children to receive nasal flu vaccine free of charge — eventually

The UK Department of Health has announced that Health Secretary Andrew Lansley has agreed to a flu vaccination program recommended by a committee of independent experts that will provide MedImmune's Fluenz intranasal vaccine to all children aged 2 to 17 at no cost. Fluenz is known as FluMist in the US. Asthmatic children and those with other risk factors were already … [Read more...] about All UK children to receive nasal flu vaccine free of charge — eventually

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