Regulatory

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 dry powder formulation is delivered by the Genuair inhaler. Almirall and Forest Labs, which owns the US rights to the … [Read more...] about Almirall submits MAA for aclidinium bromide in Europe

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 and is marketed in 50, 100, and 200 mcg dose versions. The single dose Instanyl will be available in the same dosages. "The launch … [Read more...] about European marketing approval for single dose Instanyl nasal spray

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 launch the Arcapta Neohaler in the US in the first quarter of 2012. An FDA advisory committee recommended approval of the 75 mcg dose in March 2011 … [Read more...] about FDA approves indacaterol

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 is called PecFent. “Lazanda is an important new option for patients with cancer who experience excruciating breakthrough pain," said Jeffrey … [Read more...] about FDA approval for fentanyl nasal spray

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 rights to the product; Almirall retains the rights elsewhere. The aclidinium bromide formulation is delivered via a multi-dose DPI and will … [Read more...] about Forest and Almirall submit NDA for aclidinium bromide

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 that it would vote against the authorization. Pharmaxis chose not to withdraw the marketing authorization … [Read more...] about Another negative opinion from CHMP on Bronchitol

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 that can serve as lubricants and surfactants. The company says that it has data showing that LMS-611 has "significant … [Read more...] about Lamellar gets orphan designation for inhaled CF drug