Regulatory

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 . . .

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… Read more . . .

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… Read more . . .