Regulatory

Alexza Pharmaceuticals has submitted a marketing authorization application to the European Medicines Agency (EMA) for its Adasuve Staccato loxapine for adult patients with schizophrenia or with bipolar disorder. Grupo Ferrer will market Adasuve in Europe if the EMA approves the application. In the US, the company resubmitted an NDA for the product in August 2011 after … [Read more...] about Alexza submits MAA for Adasuve inhaled loxapine

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) Pharmaxis has adopted a positive opinion recommending the approval of a marketing authorization for Bronchitol inhaled dry powder mannitol formulation “for the treatment of cystic fibrosis in adults as an add‐on therapy to best standard of care,” says Pharmaxis. Patients with CF who … [Read more...] about CHMP adopts positive recommendation on Bronchitol MAA

SkyePharma has announced a delay in the review of the European Marketing Authorisation Application ("MAA") for the Flutiform fluticasone propionate/formoterol fumarate metered dose inhaler (MDI) because the 21 Concerned Member States failed to reach consensus during the designated time period. Mundipharma, which has licensed European rights to Flutiform, filed the MAA … [Read more...] about Concerned Member States fail to reach consensus on Flutiform MAA

Days after Insmed announced that the FDA was continuing its hold on Phase 3 clinical trials of Arikace inhaled liposomal amikacin for the treatment of cystic fibrosis, the company says that the FDA has also requested additional data on Arikace before continuing a Phase 3 trial in patients with non-tuberculous mycobacterial (NTM) lung disease. The FDA initially … [Read more...] about FDA requires more data on Arikace inhaled amikacin for NTM lung disease

The FDA has notified Insmed Incorporated that it will continue a clinical hold on Phase 3 trials of the company's Arikace liposomal amikacin inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients. The company says that it has yet to receive word from the FDA about the hold placed on the Arikace trials in patients with … [Read more...] about Clinical hold on Arikace Phase 3 trials for CF to continue

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

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

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