Regulatory
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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According to Insmed, the US FDA has lifted the clinical hold on Arikace liposomal amikacin for inhalation for the treatment of patients with non-tuberculous mycobacteria (NTM) lung disease. In October 2011, the FDA had asked… Read more . . .
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Mumbai-based pharmaceutical and biotechnology company Wockhardt says that it will launch its generic version of GSK’s Flonase fluticasone nasal spray in the US immediately after having received approval from the US FDA. The company will… Read more . . .
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GlaxoSmithKline and Theravance have announced the completion of Phase 3 studies of their Relovair fluticasone furoate/vilanterol DPI for COPD. One Phase 3 study for the treatment of asthma remains to be completed. Despite the fact… Read more . . .
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Pharmaxis has announced that it “filed a minor resubmission with the Pharmaceutical Benefits Advisory Committee (PBAC)” for its Bronchitol mannitol dry powder inhaler for the treatment of cystic fibrosis. According to the company, the committee’s… Read more . . .
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In an article in the December 15 issue of the New England Journal of Medicine, regulators from the FDA’s Center for Drug Evaluation and Research (CDER), with Badhul Chowdhury, director of Division of Pulmonary, Allergy,… Read more . . .
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After meeting to discuss concerns about the safety of Alexza Pharmaceutical’s Adasuve Staccato loxapine, the FDA’s Psychopharmacologic Drugs Advisory Committee voted 9 to 8, with 1 abstention, to recommend approval for a single dose in… 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