Aptar Pharma has announced that the Zetonna nasal aerosol device recently launched in the US includes a customized Aptar Landmark dose indicator, the result of a six-year collaboration with Sunovion. Zetonna is delivered by a pressurized metered dose inhaler, and the FDA recommends that all new pMDI products have an integrated dose counter. Aptar Pharma … [Read more...] about Aptar dose indicator on newly-approved nasal aerosol
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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
Lupin to market Onbrez inhalation capsules in India
According to a report in The Business Standard, Novartis India has announced an agreement with Lupin to sell the Onbrez indacaterol inhalation capsules for the treatment of COPD in India. The newspaper cited "an industry source" for the information. The article says that the capsules would be available in two doses, 150 mg and 300 mg. Few other details were … [Read more...] about Lupin to market Onbrez inhalation capsules in India
Sunovion launches Zetonna nasal aerosol in US
According to Sunovion Pharmaceuticals, Zetonna ciclesonide nasal aerosol for the treatment of perennial and seasonal allergic rhinitis is now available throughout the US. The company announced in May that it would launch the product by this fall. Sunovion also markets Omnaris ciclesonide nasal spray for the treatment of allergic rhinitis and Alvesco ciclesonide … [Read more...] about Sunovion launches Zetonna nasal aerosol in US
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