Regulatory

MAP Pharmaceuticals has resubmitted its New Drug Application (NDA) for Levadex inhaled dihydroergotamine for the treatment of migraine to the FDA, the company has announced. The FDA issued a complete response letter to MAP in March, 2012 and a form 483 to its contract manufacturer. MAP President and CEO Timothy S. Nelson said, "We have worked diligently on our … [Read more...] about MAP resubmits Levadex NDA

As expected, the European Commission has approved Novartis's Seebri Breezhaler glycopyrronium bromide DPI for the treatment of COPD. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for glycopyrronium in June 2012. The announcement comes just days after the announcement of the approval of Seebri … [Read more...] about EC approves Seebri Breezhaler

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Novartis's Seebri glycopyrronium bromide inhalation capsules, delivered by the Breezhaler DPI, for the treatment of COPD. The product should be available in Japan by the end of 2012. The glycopyrronium inhalation formulation was co-developed by Sosei and Vectura, which licensed it to Novartis … [Read more...] about Seebri inhalation capsules approved in Japan

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

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

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

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

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