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PADAC sets meeting date for discussion of Anoro Ellipta NDA

The FDA has announced that its Pulmonary-Allergy Drugs Advisory Committee (PADAC) will hold a public meeting on September 10, 2013 to discuss Glaxo's NDA for the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD. GSK submitted the NDA for the product in December 2012. The FDA will post background materials no later than two business days before … [Read more...] about PADAC sets meeting date for discussion of Anoro Ellipta NDA

Aradigm gets grant for inhaled liposomal ciprofloxacin studies for treatment of NTM

The US National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), has awarded a Small Business Initiative Research (SBIR) grant of approximately $278,000 to Aradigm to study the use of Aradigm’s Pulmaquin and Lipoquin inhaled liposomal ciprofloxacin products for the treatment of pulmonary non-tuberculous mycobacteria … [Read more...] about Aradigm gets grant for inhaled liposomal ciprofloxacin studies for treatment of NTM

FDA advisory committee recommends approval of Nasacort AQ nasal spray OTC

According to Sanofi, the FDA's Nonprescription Drugs Advisory Committee (NDAC) voted 10 to 6, with two members abstaining, to recommend making Nasacort AQ triamcinolone acetonide nasal spray available without a prescription in the US. If the FDA approves the application, Sanofi's consumer healthcare division, Chattem, Inc. will market Nasacort AQ. Sanofi US Chief … [Read more...] about FDA advisory committee recommends approval of Nasacort AQ nasal spray OTC

Intranasal aerosol proposed as treatment for snakebite

A group of researchers has published an article in Clinical Case Reports describing successful reversal of induced paralysis in a human volunteer after administration of intranasal aerosolized neostigmine, an anticholinesterase. According to the article, IV administration of anticholinesterases is the first-line treatment for neurotoxic snakebite when antivenom is … [Read more...] about Intranasal aerosol proposed as treatment for snakebite

Patient advocacy group asks FDA to maintain prescription status for corticosteroid nasal sprays

Patient advocacy organization Allergy & Asthma Network Mothers of Asthmatics (AANMA) has released data from a survey of patients using intranasal corticosteroid sprays showing that 90% of the patients surveyed "said they prefer to rely on medical professionals to diagnose and manage their conditions." According to the organization, the survey also showed that more … [Read more...] about Patient advocacy group asks FDA to maintain prescription status for corticosteroid nasal sprays

Depomed acquires fentanyl nasal spray from Archimedes

Depomed has announced that it has paid $4 million for US and Canadian rights to Lazanda fentanyl nasal spray from Archimedes Pharma Limited. Lazanda was approved by the FDA for the treatment of breakthrough cancer pain in June 2011, and Archimedes launched the product in the US in October 2011. The product is known as PecFent in Europe, where it was approved in 2010. … [Read more...] about Depomed acquires fentanyl nasal spray from Archimedes