Regulatory

A goal date of March 26, 2012 has been set for the NDA submitted to the FDA for MAP Pharmaceuticals’ Levadex inhaled dihydroergotamine (DHE) for the treatment of migraine in adults. The acceptance triggered a… Read more . . .

According to Almirall, it has submitted a marketing authorization application to the European Medicines Agency (EMA) for its aclidinium bromide DPI for the treatment of COPD. Aclidinium bromide is a long-acting inhaled muscarinic antagonist; the… Read more . . .

The European Commission has granted marketing authorization for Nycomed’s single dose Instanyl fentanyl nasal spray for the treatment of breakthrough pain in cancer patients. A multi-dose Instanyl product was approved by the EC in 2009… Read more . . .

The FDA has approved Novartis’s Arcapta Neohaler with a 75 mcg once-daily dose of indacaterol for the treatment of COPD. Novartis sells an indacaterol inhaler in Europe as the Onbrez Breezhaler. The company plans to… Read more . . .

The FDA has approved Archimedes Pharma’s Lazanda fentanyl nasal spray for the treatment of breakthrough pain in cancer patients 18 years old and older. The product is already marketed in five European countries, where it… Read more . . .

Forest Laboratories and Almirall have submitted a new drug application to the FDA for their inhaled aclidinium bromide, a dry powder long-acting inhaled antimuscarinic agent for the treatment of COPD. Forest has licensed the US… Read more . . .

The Committee for Medicinal Products for Human Use (CHMP) has recommended against granting a marketing authorization to Pharmaxis’s Bronchitol inhaled dry powder mannitol formulation for the treatment of cystic fibrosis. The CHMP had previously indicated… Read more . . .

Lamellar Biomedical’s LMS-611, an inhaled Lamellasome, an artificial lamellar body, for the treatment of patients with cystic fibrosis has received orphan drug designation from the European Commission. CF patients’ lungs may be missing lamellar bodies… Read more . . .