dose strengths, such as 150 mcg and 300 mcg. It is approved in approximately 90 countries. In 2011, the FDA approved a 75 mcg once-daily dose of indacaterol under its U.S. trade name, Arcapta Neohaler, and Japanese regulatory authorities approved Onbrez Inhalation Capsules in a 150 mcg once-daily dose. In 2012, Onbrez Breezhaler 150 mcg was also approved in China. It was the first inhaled COPD product administered to patients through the low resistance Breezhaler device. Seebri Breezhaler (glycopyrronium), a long-acting muscarinic antagonist, received its first regulatory approvals in September 2012. Seebri Breezhaler (glycopyrronium) 44 mcg delivered dose (equivalent to 50 mcg glycopyrronium measured dose per capsule) received approval in the EU as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms for adult patients with COPD. In Japan, the MHLW approved once-daily Seebri (glycopyrronium) Inhalation Capsules 50 mcg glycopyrronium administered through the Breezhaler device as an inhaled maintenance bronchodilator treatment for the relief of various symptoms due to airway obstructive disease in COPD (chronic bronchitis and emphysema). Seebri is the second inhaled COPD product delivered to patients through the low resistance Breezhaler device. Tekturna/Rasilez (aliskiren) is a treatment for high blood pressure and the approved direct renin inhibitor. Tekturna/Rasilez is approved in approximately 100 countries. The product is known as Tekturna in the U.S. and Rasilez in the rest of the world. There are various Tekturna/Rasilez single-pill combination products approved in various countries, including Tekturna/Rasilez combined with the diuretic hydrochlorothiazide, sold as Tekturna HCT in the U.S. and Rasilez HCT in the EU, and Tekturna/Rasilez combined with the calcium channel blocker amlodipine, which is sold as Tekamlo in the U.S. and Rasilamlo in the EU. A triple combination of these drugs is available in the U.S., as well, combining aliskiren, amlodipine, and hydrochlorothiazide under the brand name, Amturnide. In 2012, the Tekturna/Rasilez product information was updated in the EU, the U.S., Japan, and other countries to include the addition of a contraindication against the combined use of aliskiren with an ACE inhibitor or an ARB in patients with diabetes, and a contraindication/warning against the combined use of aliskiren with an ACE inhibitor or an ARB in patients with renal impairment. Established Medicines Reclast/Aclasta (zoledronic acid 5 mg) is the bisphosphonate infusion for the treatment of different forms of osteoporosis, and for the treatment of Paget's disease of the bone in men and women. Sold as Reclast in the U.S. and Aclasta in the rest of the world, the product is approved in approximately 100 countries, including the U.S., the EU member states, and Canada, and is the bisphosphonate approved to reduce the incidence of fractures at all three primary fracture sites (hip, spine, and non-spine) in the treatment of postmenopausal osteoporosis. The Reclast/Aclasta label is expanded in the EU and the U.S. to include the reduction in the incidence of clinical fractures after a low trauma hip fracture. The EU has also approved Aclasta for the treatment of osteoporosis in men at increased risk of fracture and for the treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture. Reclast is also approved in the U.S. as a treatment to increase bone mass in men with osteoporosis, the prevention and treatment of glucocorticoid-induced osteoporosis in men and women, as well as for the prevention of osteoporosis in postmenopausal women. Zoledronic acid, the active ingredient in Reclast/Aclasta, is also approved in various countries in a different dosage under the trade name Zometa for certain oncology indications. Voltaren/Cataflam (diclofenac sodium/potassium/resinate/free acid) is a major non-steroidal anti-inflammatory drug for the relief of symptoms in rheumatic diseases, such as rheumatoid arthritis and osteoarthritis, and for various other inflammatory and pain conditions. Voltaren/