A company called GSC Products has launched what it says is "the world's first caffeine nasal spray" in the US. GSC says that the product, called Turbo Snort, was introduced on the Internet in January and is now sold in more than 500 independent convenience stores. GSC CEO Wayne Perry said, "By delivering caffeine through the nose, it bypasses the systemic processes … [Read more...] about Caffeine nasal spray launched in US
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European marketing approval for Forest’s Colobreathe dry powder inhaler
Forest Laboratories has received EMA approval to market Colobreathe dry powder colistimethate sodium inhalation powder for the treatment of P. aeruginosa infections in cystic fibrosis patients aged 6 years and older, according to the company. The company already markets a colistimethate sodium inhalation solution for nebulization under the brand name Colomycin in the … [Read more...] about European marketing approval for Forest’s Colobreathe dry powder inhaler
FDA advisory committee recommends approval of aclidinium bromide inhalation powder
The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 12 to 2 in favor of approval for Forest Laboratories' and Almirall's NDA for a 400 μg twice daily dose aclidinium bromide inhalation powder to treat COPD. Although the briefing materials for the advisory committee meeting raised questions about the safety of inhaled long-acting muscarinic agents … [Read more...] about FDA advisory committee recommends approval of aclidinium bromide inhalation powder
FDA posts 2011 warning letter to MDI spacer marketer
Among the warning letters posted to the FDA website on February 21, 2012 is a letter to FSC Laboratories dated June 9, 2011 detailing violations related to quality controls for the manufacture of the E-Z Spacer collapsible holding chamber for metered dose inhalers. According to the letter, a March 2011 FDA inspection found that the company "is a virtual company that … [Read more...] about FDA posts 2011 warning letter to MDI spacer marketer
FDA expresses concerns about aclidinium safety ahead of advisory committee meeting
The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) will meet on Thursday, February 23 to decide whether or not to approve Forest Labs' aclidinium bromide inhalation powder for the treatment of COPD. Forest submitted an NDA for the product in June 2011. In its briefing package for the advisory committee members, the FDA cites known cardiac safety issues … [Read more...] about FDA expresses concerns about aclidinium safety ahead of advisory committee meeting
US Patent Office issues new patent for Aradigm’s Pulmaquin
Aradigm has announced that the United States Patent and Trademark Office has issued an additional patent covering several formulations of ciprofloxacin, including the company's lead product, Pulmaquin dual release ciprofloxacin for inhalation. The patent (US Patent No. 8,119,156) will provide exclusivity for Pulmaquin until October 22, 2028. The company, which … [Read more...] about US Patent Office issues new patent for Aradigm’s Pulmaquin
New OINDP testing consultancy launched
Inhalation testing specialist Frank Chambers has launched a new analytical consultancy specializing in OINDP testing called Inhalytic. Chambers, whose most recent position was as Senior Scientist at AstraZeneca, where he performed analytical research on inhaler products, is a member of the EPAG Impactor sub-team and has published numerous scientific articles. … [Read more...] about New OINDP testing consultancy launched
FDA to review inhaled caffeine product
According to the Associated Press, the FDA will investigate the safety of Aeroshot inhalable caffeine and whether the product can be considered a dietary supplement as the manufacturer claims or if it is subject to regulation as a drug. AeroShot is manufactured by Breathable Foods, co-founded by Harvard professor David Edwards. The report says that FDA Commissioner … [Read more...] about FDA to review inhaled caffeine product
Aerogen authorized to market nebulizers in China
Irish nebulizer manufacturer Aerogen has received authorization from the Chinese State Food and Drug Administration (SFDA) to market its Aeroneb Pro and Aeroneb Go vibrating mesh nebulizers in China. The company expects to begin selling the products in the country by March 2012, with distributed handled by Gaelmed. Aerogen currently markets products in 65 countries. … [Read more...] about Aerogen authorized to market nebulizers in China
Alexza offers common stock and warrants
Alexza Pharmaceuticals, which is developing a number of inhaled drugs using its proprietary Staccato inhaler, will offer 44,000,000 shares of common stock and 44,000,000 warrants to purchase common stock at $0.50 per share for a total offer of $22 million. One warrant to purchase a common share will be sold with each common share. According to the company, the money … [Read more...] about Alexza offers common stock and warrants