According to Marinomed, the company's Coldamaris anti-virus nasal spray has been approved in Canada as a "natural health product." The over-the-counter product has been registered in Europe, where it is licensed to Boehringer Ingelheim, since 2007. Coldamaris, which contains a red algae extract called Carragelose, is approved in 38 countries as a prophylactic and … [Read more...] about Marinomed gets Canadian approval for anti-virus nasal spray
Regulatory
FDA accepts NDA for Anoro Ellipta DPI
According to GSK and Theravance, the FDA has accepted their NDA for the Anoro Ellipta umeclidinium bromide (UMEC)/vilanterol (VI) dry powder inhaler for the treatment of COPD, with a PDUFA date of December 18, 2013. The two companies submitted the NDA in December 2012. GSK and Theravance also submitted an MAA for Anoro earlier this year, and that application has … [Read more...] about FDA accepts NDA for Anoro Ellipta DPI
Next Breath receives ISO/IEC 17025:2005 accreditation
The American Association for Laboratory Accreditation (A2LA) has accredited Next Breath, LLC, to ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) 17025:2005a, the primary standard for testing and calibration labs. Next Breath offers a wide range of analytical testing services for OINDPs. Next Breath … [Read more...] about Next Breath receives ISO/IEC 17025:2005 accreditation
Pharmaxis gets financing for Bronchitol commercialization, negative recommendation from PADAC
According to Pharmaxis, the company has obtained up to $40 million from NovaQuest Pharma Opportunities Fund III for development, manufacturing, and commercialization of Bronchitol mannitol inhalation powder in the US and EU. At the same time, the company announced that Bronchitol had received a negative recommendation for the treatment of cystic fibrosis patients from … [Read more...] about Pharmaxis gets financing for Bronchitol commercialization, negative recommendation from PADAC
FDA issues warning to company for unapproved inhaler
The FDA and the US Federal Trade Commission (FTC) have issued a warning to a Florida company called Flu and Cold Defense LLC regarding its claims for an over-the-counter nasal vapor inhalation product called GermBullet. The warning cites claims such as, "[GermBullet] has been laboratory tested and shown to reduce illness-causing bacteria, cold and flu viruses and … [Read more...] about FDA issues warning to company for unapproved inhaler
Bend Research gets EU GMP certificate
The Swedish Medical Products Agency (MPA) has granted Bend Research a certificate of compliance with European Union good manufacturing practice (GMP) regulations for the company's manufacture and testing of clinical pharmaceutical supplies. All European health authorities recognize the MPA GMP certificate, as do agencies in some additional countries. Bend CEO Rod … [Read more...] about Bend Research gets EU GMP certificate
FDA advisory committee recommends approval of Striverdi Respimat
At its January 29, 2013 meeting, the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended approval of the 5 µg dose of Boehringer Ingelheim's Striverdi Respima olodaterol soft mist inhaler for the maintenance treatment of COPD. BI VP of Clinical Development and Medical Affairs, Respiratory Tunde Otulana said, “We at Boehringer Ingelheim are pleased … [Read more...] about FDA advisory committee recommends approval of Striverdi Respimat
NICE recommends TOBI Podhaler and Colobreathe for CF patients
The UK's National Institute for Health and Clinical Excellence (NICE) has issued a qualified recommendation for Forest Lab's Colobreath colistimethate sodium and Novartis's TOBI Podhaler tobramycin dry powders for inhalation as options for the treatment of P. aeruginosa lung infections in patients with cystic fibrosis. The recommendation is a final draft; the final … [Read more...] about NICE recommends TOBI Podhaler and Colobreathe for CF patients
FDA issues final cGMP rule for combination products
On January 22, 2013, the FDA published its final cGMP rule for combination products in the Federal Register. According to the rule's summary, "This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a … [Read more...] about FDA issues final cGMP rule for combination products
Meda’s Dymista gets European approval
According to Meda, the EU has approved the company's Dymista azelastine/fluticasone nasal spray for the treatment of seasonal and perennial allergic rhinitis. Meda submitted an MAA for the product in late 2011. The company announced the FDA's approval of Dymista in May 2012. The European approval was made through the decentralized procedure, and Meda says that it … [Read more...] about Meda’s Dymista gets European approval