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
Regulatory
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
Discovery Labs gets authorization for Afectair device in US
Discovery Laboratories has announced that the FDA has approved the Afectair device for marketing in the US, and the company plans a launch later this year. The company describes Afectair as "a proprietary patient interface technology that simplifies delivery of aerosolized medications to patients requiring ventilator support" and estimates that it could bring in … [Read more...] about Discovery Labs gets authorization for Afectair device in US
Meda files patent infringement suit against Apotex, Perrigo
Meda Pharmaceuticals has filed a patent infringement suit against Apotex and Perrigo in US District Court in regard to their generic versions of its Astepro azelastine nasal spray for the treatment of rhinitis. The suit alleges infringement of a patent granted to Meda in December 2011 when the two companies submitted abbreviated new drug applications for generic … [Read more...] about Meda files patent infringement suit against Apotex, Perrigo
FDA review of Adasuve application extended
According to Alexza Pharmaceuticals, the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for the Adasuve Staccato loxapine NDA from February 4, 2012 to May 4, 2012. On January 10, 2012, Alexza submitted an updated proposed Risk Evaluation and Mitigation Strategy (REMS) program, which the FDA is considering a major amendment, allowing the agency to … [Read more...] about FDA review of Adasuve application extended