Teva Respiratory says that the ProAir HFA metered dose inhaler with dose counter for the treatment of asthma is now available. The albuterol MDI with dose counter was approved by the FDA in March 2012. At the time, the company announced that the new inhaler would be available by the end of 2012. Teva says that it needed time to manufacture a sufficient inventory to … [Read more...] about Teva Pro-Air MDI with dose counter now available in US
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Mitsubishi to acquire Qualicaps
The Carlyle group has agreed to sell Mitsubishi Chemical Holdings Corporation all outstanding shares of pharmaceutical capsule manufacturer Qualicaps. Products manufactured by Qualicaps include both gelatin and hypromellose capsules for use with dry powder inhalers. Mitsubishi will pay approximately ¥55.8 billion, or about $660 million, for the company. Read … [Read more...] about Mitsubishi to acquire Qualicaps
Alexza appoints J. Kevin Buchi to board of directors
Alexza Pharmaceuticals has announced the appointment of J. Kevin Buchi to its board of directors. Buchi, who was Corporate Vice President, Global Branded Products at Teva Pharmaceutical Industries from October 2011 until May 2012, has over 30 years of experience in the pharmaceutical industry. Alexza's Adasuve loxapine inhalation powder for the treatment of … [Read more...] about Alexza appoints J. Kevin Buchi to board of directors
Discovery Labs launches Afectair system
Discovery Laboratories has announce the launch of its Afectair airway connector for the delivery of aerosolized medications to infants in neonatal or pediatric intensive care units. The disposable device enables delivery of aerosolized drugs to patients on ventilatory support at the patient interface and was initially developed in conjunction with the company's … [Read more...] about Discovery Labs launches Afectair system
FDA approves Alexza’s Adasuve loxapine inhalation powder
The FDA has approved Alexza Pharmaceutical's Adasuve loxapine inhalation powder for the treatment of agitation in patients with schizophrenia or bipolar I disorder. The Staccato loxapine inhaler will be available only under a Risk Evaluation and Mitigation Strategy (REMS) and is to be administered only in healthcare facilities enrolled in the Adasuve REMS program. Use … [Read more...] about FDA approves Alexza’s Adasuve loxapine inhalation powder
Acorda plans to submit 505(b)(2) NDA for diazepam nasal spray
Acorda Therapeutics says that it has completed its acquisition of Neuronex, including Neuronex's diazepam nasal spray formulation, for $6.8 million. The company also announced that it plans to submit a 505(b)(2) NDA in 2013 for the diazepam nasal spray as a treatment for seizures in epilepsy patients. In early 2012, Acorda paid $2 million to Neuronex as an option … [Read more...] about Acorda plans to submit 505(b)(2) NDA for diazepam nasal spray
Paul Young and Daniela Traini head up new Respiratory Technology Group
Paul M. Young and Daniela Traini have moved from the Pharmacy Faculty at the University of Sydney to the Woolcock Institute of Medical Research (WIMR) in order to establish a new Respiratory Technology team at the Institute. According to Young and Traini, "The WIMR is a world leading respiratory and sleep research organization whose aim is to foster, develop and … [Read more...] about Paul Young and Daniela Traini head up new Respiratory Technology Group
Matrixx Initiatives recalls single lot of Zicam nasal spray
Matrixx Initiatives has voluntarily recalled a single lot of Zicam Extreme Congestion Relief nasal gel spray due to contamination with Burkholderia cepacia in a single sample. Zicam is a homeopathic product available over the counter in the US. The affected lot, which was distributed to retailers throughout the US, is number 2J23. The 0.5 oz spray bottles are … [Read more...] about Matrixx Initiatives recalls single lot of Zicam nasal spray
GSK and Theravance submit NDA for UMEC/VI inhaler
GlaxoSmithKline and Theravance say that they have submitted an NDA to the US FDA for an umeclidinium bromide (UMEC)/vilanterol (VI) dry powder inhaler for the treatment of COPD to be marketed under the name "Anoro Ellipta." The LAMA/LABA combination is a once-daily treatment. According to the companies, they plan regulatory filings for UMEC/VI in the European … [Read more...] about GSK and Theravance submit NDA for UMEC/VI inhaler
SkyePharma gets $8 million settlement from AstraZeneca for Pulmicort deal termination
SkyePharma has announced that AstraZeneca will pay $8 million in January 2013 "to settle certain disputes" resulting from AZ's termination of their licensing deal for the Pulmicort MDI. The deal was terminated after AZ discontinued production of the inhaler in early 2011 due to manufacturing problems. At the time, SkyePharma, which developed the product, said that … [Read more...] about SkyePharma gets $8 million settlement from AstraZeneca for Pulmicort deal termination