The US FDA has approved Boehringer Ingelheim's Combivent Respimat tiotropium/albuterol inhalation spray for the treatment of COPD. The Combivent Respimat soft mist inhaler will replace the Combivent CFC-propelled MDI, which is to be phased out by December 31, 2013. The Combivent Respimat inhaler, which does not use any propellant, will be available by mid-2012. … [Read more...] about FDA approves Combivent Respimat inhaler
Regulatory
British Pharmacopoeia adds working party for inhaled products, seeks input
According to the British Pharmacopoeia website: "The British Pharmacopoeia Commission has recently endorsed the formation of a new Working Party for Inhaled Products (IP). The remit of the Working Party will be to review the current published monographs for Inhaled Products and associated General Monographs and Supplementary Chapters." "Stakeholders are invited … [Read more...] about British Pharmacopoeia adds working party for inhaled products, seeks input
Novartis has filed MAA for Seebri Breezhaler in Europe
Novartis has filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for its NVA237 glycopyrronium bromide dry powder inhaler, which will be called the Seebri Breezhaler. The MAA once-daily long-acting antimuscarinic (LAMA) triggered a $5 million milestone payment to Sosei, which co-developed the product with Vectura and licensed it … [Read more...] about Novartis has filed MAA for Seebri Breezhaler in Europe
Alexza announces PDUFA goal date for Staccato loxapine
After the FDA's acceptance of Alexza Pharmaceuticals's resubmitted NDA for Adasuve, the company has announced that the Prescription Drug User Fee Act (PDUFA) goal date will be February 4, 2012. Alexza had received a complete response letter for the Staccato inhaled loxapine product in October 2010 and resubmitted the application for approval of Adasuve as a treatment … [Read more...] about Alexza announces PDUFA goal date for Staccato loxapine
FDA approves mometasone nasal implant for chronic sinusitis
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
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