Regulatory

The European Commission (EC) has approved SkyePharma’s flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of asthma in the 21 European countries using the decentralized procedure. The CHMP issued a positive opinion for flutiform in… Read more . . .

A study by the European Pharmaceutical Aerosol Group (EPAG) titled “Effect of Sampling Volume on Dry Powder Inhaler (DPI)-Emitted Aerosol Aerodynamic Particle Size Distributions (APSDs) Measured by the Next-Generation Pharmaceutical Impactor (NGI) and the Andersen… Read more . . .

According to Novartis, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Seebri Breezhaler glycopyrronium/NVA237 DPI for the treatment of COPD. Novartis submitted the MAA in September 2011.… Read more . . .

Alexza Pharmaceuticals says that it has resubmitted its NDA for Adasuve inhaled loxapine for the treatment of agitation in patients with bipolar disorder or schizophrenia; the company received a Complete Response Letter for the Adasuve… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .