According to Insmed, the FDA has lifted the clinical hold placed on Arikace liposomal amikacin for inhalation for the treatment of pseudomonas lung infections in cystic fibrosis patients in July 2011. A hold on Arikace for non-tuberculous mycobacteria (NTM) lung disease was lifted in January of this year. Insmed says that it has reached an agreement with the FDA … [Read more...] about FDA lifts clinical hold on Arikace inhaled liposomal amikacin
Regulatory
Alexza gets complete response letter for Adasuve
The FDA has issued a complete response letter to Alexza Pharmaceuticals regarding its New Drug Application (NDA) for Adasuve loxapine inhalation powder for the treatment of agitation associated with schizophrenia or bipolar I disorder in adults. The FDA had previously extended the review period after Alexza submitted an updated proposed Risk Evaluation and Mitigation … [Read more...] about Alexza gets complete response letter for Adasuve
FDA approves Meda’s Dymista nasal spray, warns company on Astepro script
According to Meda, the FDA has approved Meda's Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis. Meda filed the NDA approximately one year ago, in April 2011. Meda CEO Anders Lonner said, "Allergic rhinitis is an increasing problem. Many patients have severe symptoms that cause inability to work … [Read more...] about FDA approves Meda’s Dymista nasal spray, warns company on Astepro script
Pharmaxis gets marketing authorization for bronchitol in Europe
The European Commission has granted marketing authorization to Pharmaxis for its Bronchitol mannitol inhalation powder for the treatment of cystic fibrosis in patients 18 and over. In October 2011, the CHMP adopted a positive opinion regarding approval of the drug after several prior negative opinions. The company will officially launch the product in Europe at … [Read more...] about Pharmaxis gets marketing authorization for bronchitol in Europe
Novartis expected to file NDAs for QVA149 and NVA237 in 2014
According to Sosei, Novartis and the FDA have agreed on Phase 3 trial design for QVA149 indacaterol/glycopyrronium bromide and NVA237 glycopyrronium bromide, which should put the company on track to file an application for NVA237 early in 2014 and an application for QVA149 by the end of that year. Novartis licensed NVA 237 from Sosei and Vectura. Both Sosei and … [Read more...] about Novartis expected to file NDAs for QVA149 and NVA237 in 2014
CHMP issues positive opinion on flutiform
The EMA's Committee for Medicinal Products for Human Use ("CHMP") has issued a positive opinion on SkyePharma's MAA for its flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of asthma. The MAA had been referred to CHMP after the concerned member states failed to reach consensus on the application. According to SkyePharma, the company … [Read more...] about CHMP issues positive opinion on flutiform
MAP gets new patent for Levadex, schedules meeting with FDA
MAP Pharmaceuticals has announced that it has a meeting scheduled with the FDA during the second quarter of this year to discuss the complete response letter it received for its Levadex inhaled dihydroergotamine application. MAP President and CEO Timothy S. Nelson said, "We are pleased that the FDA has scheduled a meeting with us to discuss the issues contained in the … [Read more...] about MAP gets new patent for Levadex, schedules meeting with FDA
British Pharmacopoeial Commission requests comment on changes to inhaled product monographs
The British Pharmacopoeial Commission is requesting comment from OINDP manufacturers regarding proposed changes to its inhaled product monographs. The BP has posted a draft document authored by its Inhaled Products Working Party and has asked that manufacturers of MDIs, DPIs, and nebulizer solutions submit comments along with any relevant data. The draft document … [Read more...] about British Pharmacopoeial Commission requests comment on changes to inhaled product monographs
European rights to aclidinium bromide to Menarini, review period extended by the FDA
Almirall has licensed European rights to aclidinium bromide, both as a monotherapy and in combination with formoterol to Italian pharmaceutical company Menarini. The agreement covers most of the EU except for the UK, the Netherlands and the Nordic countries, plus several additional countries, including Russia and Turkey. Almirall CEO Eduardo Sanchiz explained, … [Read more...] about European rights to aclidinium bromide to Menarini, review period extended by the FDA
MAP gets complete response letter for Levadex inhaled dihydroergotamine
The FDA has issued a complete response letter to MAP Pharmaceuticals' NDA for Levadex dihydroergotamine inhalation aerosol for the treatment of migraine headaches. According to MAP, "the FDA requested that the Company address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. … [Read more...] about MAP gets complete response letter for Levadex inhaled dihydroergotamine