Regulatory
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
Upcoming Events
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA