The British Pharmacopoeia (BP) Inhaled Products Working Party has published its recommendations for BP monographs for inhalation as of September 17, 2012. According to the document, "Safety and efficacy are critical considerations; the Working Party has taken the view that the inhalation monographs would ensure products that are safe and efficacious by maintaining … [Read more...] about British Pharmacopoeia publishes policy document on inhaled products
Regulatory
GSK submits Japanese NDA for FF/VI DPI, gets PDUFA goal date in US
GlaxoSmithKline says that it submitted a Japanese New Drug Application (JNDA) for its fluticasone furoate (FF)/vilanterol(VI) dry powder inhaler for the treatment of COPD and asthma on September 25, 2012. The FF/VI combination will be delivered by a DPI known as the Ellipta. GSK and Theravance also announced the acceptance of the FF/VI NDA in the US and said that … [Read more...] about GSK submits Japanese NDA for FF/VI DPI, gets PDUFA goal date in US
FDA approves Acton’s Aerospan flunisolide MDI
Acton Pharmaceuticals has announced plans to launch its Aerospan flunisolide HFA metered dose inhaler in early 2013 after having received FDA approval for the MDI. The product is approved for for the maintenance treatment of asthma in patients 6 years old and older, and the Aerospan device includes a built-in spacer. Acton acquired the Aerospan NDA from Forest … [Read more...] about FDA approves Acton’s Aerospan flunisolide MDI
FDA approves InnoPharma’s acetylcysteine inhalation solution
The FDA has approved InnoPharma's ANDA for acetylcysteine solution. The New Jersey company has a deal with Fresenius Kabi USA to market acetylcysteine solution in the US, where there has been a shortage of the product. Bedford Laboratories recalled acetylcysteine solution earlier this year and American Regent/Luitpold has experienced recurring manufacturing problems. … [Read more...] about FDA approves InnoPharma’s acetylcysteine inhalation solution
FDA committee recommends approval of tobramycin inhalation powder
The Anti-Infective Drugs Advisory Committee (AIDAC) of the FDA voted 13 to 1 in favor of approval of Novartis's tobramycin inhalation powder (TIP) for the treatment of P. aeruginosa-infected cystic fibrosis patients six years old and older. Briefing materials for the meeting had questioned the safety and efficacy of TIP and whether it had any advantages compared to … [Read more...] about FDA committee recommends approval of tobramycin inhalation powder
FDA questions for Novartis about Tobi Podhaler prior to advisory committee meeting
The FDA briefing materials for the September 5, 2012 meeting of the Anti-Infective Drugs Advisory Committee, which will consider the use of Novartis's Tobi tobramycin inhalation powder (TIP) for the treatment of P. aeruginosa infections in cystic fibrosis patients, question both the efficacy and safety of the product, especially when compared to TOBI tobramycin … [Read more...] about FDA questions for Novartis about Tobi Podhaler prior to advisory committee meeting
Positive Phase 3 results for QVA 149, filings expected by the end of the year
According to Novartis, the latest Phase 3 study of the QVA149 indacaterol/glycopyrronium DPI demonstrated a significant reduction in exacerbations of moderate-to-severe COPD compared to the Seebri Breezhaler glycopyrronium bromide DPI alone. The company says that it plans to submit regulatory filings in Europe and Japan by the end of 2012 and in the US at the end of … [Read more...] about Positive Phase 3 results for QVA 149, filings expected by the end of the year
GSK to submit applications for UMEC/VI inhaler this year
GlaxoSmithKline says that it will begin regulatory submissions for its umeclidinium bromide (UMEC) and vilanterol (VI) dry powder inhaler for the treatment of COPD by the end of 2012. GSK is partnered with Theravance on this product, which will be delivered by the Ellipta inhaler. The two companies also announced the completion of the Phase 3 clinical program. … [Read more...] about GSK to submit applications for UMEC/VI inhaler this year
Alexza gets EU GMP certificate for Adasuve manufacturing facility
Alexza Pharmaceuticals has received a EU Certificate of GMP Compliance of a Manufacturer subsequent to a May 2012 inspection by the Agencia Espanola de Medicamentos y Productos Sanitarios, the company has announced. Alexza plans to manufacture Adasuve Staccato loxapine at the facility in Mountain View, CA. Alexza says that the initial certificate will remain valid … [Read more...] about Alexza gets EU GMP certificate for Adasuve manufacturing facility
Symbicort Turbuhaler approved for COPD in Japan
Astellas and AstraZeneca have announced the approval of Symbicort Turbuhaler for COPD. The budesonide/formoterol fumarate DPI has been available for the treatment of asthma in Japan since January 2010. The two companies entered an agreement to co-promote Symbicort Turbuhaler in Japan in August 2009. According to the companies, "The approval of Symbicort … [Read more...] about Symbicort Turbuhaler approved for COPD in Japan