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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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 . . .

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 . . .