Regulatory
-
The US FDA has accepted the new drug application (NDA) filed by Teva on May 24, 2011 for its beclomethasone dipropionate (BDP) hydrofluoroalkane nasal spray for the treatment of seasonal allergic rhinitis (SAR) and perennial… Read more . . .
-
The UK Medicines and Healthcare products Regulatory Agency (MHRA) is warning consumers against using a “fake tan nasal spray” marketed as Ubertan. According to the agency, the product comes in two versions, one of which… Read more . . .
-
The US FDA has notified Insmed that it has placed a clinical hold on Insmed’s trials of Arikace liposomal amikacin for inhalation. The ongoing Phase 3 program for the use of Arikace in cystic fibrosis… Read more . . .
-
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 . . .
-
Armstrong Pharmaceuticals is advising customers to stockpile its Primatene Mist epinephrine MDI before the FDA ban on CFC formulations takes effect on December 31, 2011. The company says that it is “actively finalizing its internal… 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 . . .
-
MedImmune has announced its submission of a supplemental Biologics License Application to the FDA for a version of its FluMist intranasal influenza vaccine that includes 4 strains of influenza virus as opposed to the usual… 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 . . .
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
May 10-May 14: RDD 2026, Phoenix, AZ, USA
May 15-May 16: ATS Respiratory Innovation Summit 2026, Orlando, FL, USA
May 17-May 20: ATS International Conference 2026, Orlando, FL, USA
June 10: SMI.London 2026, London, UK
July 13-July 16: 2026 ISAM Congress, Taipei, Taiwan