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
Regulatory
FDA approves indacaterol
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
FDA approval for fentanyl nasal spray
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 and Almirall submit NDA for aclidinium bromide
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
Another negative opinion from CHMP on Bronchitol
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 gets orphan designation for inhaled CF drug
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
SPARC announces plans to launch new DPI
Sun Pharma Advanced Research Company (SPARC) has announced completion of Phase 3 studies for a new dry powder inhaler and its intention to launch a product based on the novel DPI in India by the end of the 2nd quarter of the fiscal year. In addition, the company said, it plans to file an IND in the US by the end of the fiscal year. The DPI delivers a dry powder … [Read more...] about SPARC announces plans to launch new DPI
Aradigm ciprofloxacin for bronchiectasis gets orphan drug designation
The US FDA has granted orphan drug designation to Aradigm Corporation's dual release ciprofloxacin for inhalation (DRCFI) for the treatment of bronchiectasis. The company's liposomal ciprofloxacin for inhalation (CFI) already has orphan drug designation from the FDA for the treatment of bronchiectasis and for cystic fibrosis. The dual release formulation combines … [Read more...] about Aradigm ciprofloxacin for bronchiectasis gets orphan drug designation
Elpen’s Advair copy approved by Sweden
Reuters is reporting that the Swedish Medical Products Agency has approved a fluticasone/salmeterol DPI manufactured by Greek pharmaceutical company Elpen. The approval apparently took place in May 2011 but was not announced. The company has not said when or if it will launch the product in European countries outside of Greece. Elpen has been marketing the inhaler … [Read more...] about Elpen’s Advair copy approved by Sweden
FDA accepts NDA for Nycomed nasal aerosol
The US FDA has accepted the filing of the new drug application for its ciclesonide nasal aerosol, according to Nycomed and Sunovion. The product is an HFA formulation of ciclesonide delivered by a metered dose device for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis in patients 12 years old and older. Sunovion (formerly Sepracor) owns the … [Read more...] about FDA accepts NDA for Nycomed nasal aerosol