Regulatory

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for approval of Almirall's Eklira Genuair aclidinium DPI for the treatment of COPD. The Genuair inhaler is a proprietary multidose, cartridge-based dry powder inhaler. Almirall Chief Scientific Officer Bertil Lindmark commented,”The … [Read more...] about CHMP recommends approval of aclidinium for COPD in Europe

According to Sun Pharma, the FDA has approved an Abbreviated New Drug Application (ANDA) for a generic version of azelastine nasal spray submitted by a Sun subsidiary. Sun notes that the US sales of azelastine nasal spray are about $144 million annually. Astelin and Astepro azelastine sprays are distributed in the US by Meda. Astepro is a newer formulation … [Read more...] about FDA approves generic version of Astelin nasal spray

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

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

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

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

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