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
Regulatory
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
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
Herbal nasal sprays recalled
A Dallas, TX company called Wholistic Herbs Inc. has recalled all of the nasal spray products it distributed from March 2009 through February 2012 under the name "Koff & Kold" and "Kold Sore" after an FDA inspection determined that the products are not sterile. The products were distributed through the company's website, which is no longer accessible, and through … [Read more...] about Herbal nasal sprays recalled
EMA outlines objections to Adasuve MAA in Day 80 assessment report
Alexza Pharmaceuticals says that the Day 80 Assessment Report it has received from the European Medicines Agency (EMA) regarding its Marketing Authorization Application (MAA) for Adasuve Staccato loxapine indicates that the report "outlines major objections pertaining to the extrapolation of the Phase 3 study population to the intended patient population, pulmonary … [Read more...] about EMA outlines objections to Adasuve MAA in Day 80 assessment report
Insmed moving ahead with Arikace trials despite FDA clinical hold
Insmed Incorporated has announced that it will go ahead with two clinical trials of its Arikace liposomal amikacin for inhalation for non-tuberculous mycobacteria (NTM) lung disease and for P. aeruginosa infections in CF patients despite the continuing clinical hold placed by the FDA on the latter application. The FDA lifted the hold on Arikace for NTM earlier … [Read more...] about Insmed moving ahead with Arikace trials despite FDA clinical hold
Almirall files new applications for Sativex in Europe
Almirall has announced the filing of new applications for its Sativex endocannabinoid oromucosal spray for the treatment of spasticity in multiple sclerosis in ten additional countries: Belgium, Finland, Iceland, Ireland, Luxemburg, the Netherlands, Norway, Poland, Portugal and Slovakia. The product is currently available in Denmark, Germany, Spain, UK, Canada, and … [Read more...] about Almirall files new applications for Sativex in Europe
FDA clears Neurelis IND for intranasal diazepam
The FDA has accepted an Investigational New Drug application (IND) submitted by San Diego, CA pharmaceutical company Neurelis. The company is cleared to begin clinical trials for the development of its NRL-1 intranasal diazepam for the treatment of acute breakthrough seizures. According to the company, it filed the IND "based upon the encouraging human pharmacokinetic … [Read more...] about FDA clears Neurelis IND for intranasal diazepam
Optinose files IND for intranasal sumatriptan
According to OptiNose, it filed an investigational new drug (IND) application for an intranasal sumatriptan product with the US FDA in December, 2011, and the FDA has given OptiNose permission to proceed. The company now plans to begin Phase 3 trials in adults with acute migraine. “This filing signals an important milestone in our quest to deliver improved relief … [Read more...] about Optinose files IND for intranasal sumatriptan