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INDUSTRY NEWS Teva simultaneously launches branded and generic fluticasone propionate/salmeterol inhalers providing same APIs as GSK's Advair Diskus ® JERUSALEM, ISRAEL—Business Wire reports that Teva Pharmaceu- tical Industries, Ltd. has announced the simultaneous launch of its AirDuo ™ RespiClick ® (fluticasone propionate and salmeterol) inhala- tion powder and its authorized generic inhaler, both used for the treatment of asthma in patients aged 12 years and older who are uncon- trolled on an inhaled corticosteroid (ICS) or whose disease severity c l e a r l y w a r r a n t s t h e u s e o f a n ICS/long-acting beta 2 -adrenergic agonist (LABA) combination. AirDuo RespiClick and its autho- rized generic are fixed-dose combi- nation asthma therapies containing the same active pharmaceutical ingredients (APIs) found in Advair Diskus ® (fluticasone propionate 250 mcg and salmeterol 50 mcg inhala- tion powder) and Advair ® HFA (fluticasone propionate 45 mcg and s a l m e t e r o l 2 1 m c g i n h a l a t i o n aerosol) from GlaxoSmithKline, however Reuters notes they deliver [different] doses than the Advair inhalers. AirDuo RespiClick was approved by the US Food and Drug Administration (FDA) in January 2017 in three doses: 232/14 mcg, 113/14 mcg and 55/14 mcg admin- istered as one inhalation twice daily. Teva anticpates that, between its two inhalers, the authorized generic will generate more sales. Teva's RespiClick breath-activated, multi- dose dry powder inhaler is also used with other approved medicines in Teva's respiratory product portfolio. Sunovion announces Utibron™ Neohaler® available in US MARLBOROUGH, MA—Busi- ness Wire reports that Sunovion Pharmaceuticals, Inc. has announced Utibron ™ Neohaler ® (indacaterol/ glycopyrrolate) inhalation powder is available in the United States for the long-term maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary dis- ease (COPD), including chronic bronchitis and/or emphysema. Utibron Neohaler is a twice-daily combination long-acting beta agonist and long-acting muscarinic antago- nist (LABA/LAMA) and is not indi- cated for the treatment of asthma or for relief of sudden symptoms of C O P D . I n D e c e m b e r 2 0 1 6 , Sunovion entered into an exclusive license agreement with Novartis for the US commercialization rights to Utibron Neohaler, which received approval from the US Food and Drug Administration (FDA) in October 2015. During the 2017 fis- cal year in the US, Sunovion also expects to launch the Novartis Seebri ™ Neohaler, approved by the FDA in 2015, and begin promoting the Novartis Arcapta ® Neohaler, launched in the US in 2012. Amneal introduces its first nasal spray: Generic Nasonex ® BRIDGEWATER, NJ—PRNews - wire reports that Amneal Pharmaceu- Inhalation JUNE2017 7

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