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
Regulatory
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
Health Canada to review calcitonin nasal spray risks
In the wake of the EMA's recent recommendation against use the use of calcitonin nasal sprays due to an increased risk of cancer, Health Canada says that it is also evaluating the risks of calcitonin products. Novartis, its generic division Sandoz, and Apotex market calcitonin nasal sprays in Canada. The agency, which says that it has not received any reports of … [Read more...] about Health Canada to review calcitonin nasal spray risks
Watson gets FDA approval for budesonide, sued over levalbuterol
The FDA has approved Watson Pharmaceuticals' Abbreviated New Drug Application (ANDA) for a generic version of Pulmicort Respules. The budesonide inhalation suspension 0.25mg/2mL and 0.5mg/2mL ampules are the subject of an ongoing patent dispute with AstraZeneca. Watson says that it if it prevails in court, it will launch the budesonide product by the end of this … [Read more...] about Watson gets FDA approval for budesonide, sued over levalbuterol
Health Canada issues advisory on potential Pulmicort Turbuhaler device failure
Health Canada has issued an advisory to health care professionals that "AstraZeneca Canada has received a small number of product complaints for Pulmicort Turbuhaler, 200 µg per metered dose (200 doses) regarding the malfunction of the delivery device that results in a failure to dispense the dose of medication." According to the notice, the devices sometimes fail to … [Read more...] about Health Canada issues advisory on potential Pulmicort Turbuhaler device failure