The FDA has approved a pre-market approval (PMA) application from Intersect ENT for its Propel mometasone furoate drug delivery implant for the treatment of chronic sinusitis. The dissolvable device is inserted in the sinus cavity during surgery and maintains the opening of the ethnoid sinus while it delivers the corticosteroid to the sinus lining. David W. … [Read more...] about FDA approves mometasone nasal implant for chronic sinusitis
Regulatory
MannKind and FDA agree on design of new inhaled insulin trials
After a meeting with the FDA, MannKind Corporation has announced that the company and the agency have confirmed protocols for new efficacy and safety studies of Afrezza inhaled insulin. The original studies of Afrezza were conducted with MedTone inhaler, and in May, the FDA asked MannKind to conduct new trials with the new Dreamboat inhaler in patients with type 1 … [Read more...] about MannKind and FDA agree on design of new inhaled insulin trials
FDA accepts NDA for Teva HFA “dry” nasal spray
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 allergic rhinitis (PAR). The BDP Nasal HFA spray uses the same formulation as Teva's Qvar inhalation aerosol, an inhaled corticosteroid (ICS) … [Read more...] about FDA accepts NDA for Teva HFA “dry” nasal spray
MHRA issues warning on Ubertan nasal spray
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 contains "melanotan II, an unlicensed medicine with no evidence of safety, quality or that it works, and with unknown side effects" and another that … [Read more...] about MHRA issues warning on Ubertan nasal spray
Clinical hold placed on Arikace trials
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 (CF) patients with P. aeruginosa lung infections and patients with non-tuberculous mycobacterial (NTM) lung disease will be suspended pending review of additional data … [Read more...] about Clinical hold placed on Arikace trials
FDA accepts NDA submission for the Levadex dry powder inhaler
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 $20 million milestone payment to MAP from Allergan, which has partnered with MAP on development of the product in the US. Ownership of the NDA will be retained … [Read more...] about FDA accepts NDA submission for the Levadex dry powder inhaler
Armstrong advises customers to stock up on Primatene Mist
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 development" of an HFA formulation but warns that there is likely to be a period of time after the ban goes into effect before the new … [Read more...] about Armstrong advises customers to stock up on Primatene Mist
Almirall submits MAA for aclidinium bromide in Europe
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
MedImmune submits supplemental biologics license application for new version of FluMist
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 3 strains. The new version adds an additional influenza B strain and will include both B/Yamagata and B/Victoria, which have circulated recently, … [Read more...] about MedImmune submits supplemental biologics license application for new version of FluMist
European marketing approval for single dose Instanyl nasal spray
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