Selected second quarter product approvals

Company

Approvals

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN)

Japan approves Soliris eculizumab to treat paroxysmal nocturnal hemoglobinuria (PNH)

Amgen Inc. (NASDAQ:AMGN)

FDA approves Prolia denosumab to treat osteoporosis in postmenopausal women whoare at high risk of fractures or have failed or are intolerant to other osteoporosis therapy; EC approves Prolia to treat osteoporosis in postmenopausal women and to treat bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures

BioAlliance Pharma S.A. (Euronext:BIO)

FDA approves Oravig miconazole to treat oropharyngeal candidiasis

Celgene Corp. (NASDAQ:CELG)

Japan approves Revlimid lenalidomide in combination with dexamethasone to treat relapsed or refractory multiple myeloma (MM)

Cipher Pharmaceuticals Inc. (TSX:DND)

FDA approves Cip-tramadol ER to treat moderate to moderately severe chronic pain

Dendreon Corp. (NASDAQ:DNDN)

FDA approves Provenge sipuleucel-T to treat metastatic castrate-resistant prostate cancer

Genmab A/S (CSE:GEN)/

EC grants conditional approval for Arzerra ofatumumab to treat chronic lymphocytic

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

leukemia (CLL) refractory to fludarabine and alemtuzumab

Genzyme Corp. (NASDAQ:GENZ)

FDA approves Lumizyme alglucosidase alfa to treat late (non-infantile) onset Pompe's disease in patients who do not have evidence of cardiac hypertrophy

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

EC conditionally approves Votrient pazopanib for first-line treatment of advanced renal cell carcinoma (RCC)

GW Pharmaceuticals plc (LSE:GWP)/ Bayer AG (Xetra:BAY)

U.K. approves Sativex to treat spasticity due to multiple sclerosis (MS)

Hospira Inc. (NYSE:HSP)

EC approves Nivestim filgrastim to prevent febrile neutropenia and to reduce the duration of chemotherapy-induced neutropenia

Inspire Pharmaceuticals Inc. (NASDAQ:ISPH)/ Santen Pharmaceutical Co. Ltd. (Tokyo:4536; Osaka:4536)

Japan approves Diquas diquafosol tetrasodium ophthalmic solution 3% to treat dry eye

Johnson & Johnson (NYSE:JNJ)

FDA approves Pancreaze pancrelipase delayed-release capsules to treat pancreatic exocrine insufficiency

Merck & Co. Inc. (NYSE:MRK)

FDA approves Dulera mometasone/formoterol inhalation aerosol to treat asthma

Novartis AG (NYSE:NVS; SIX:NOVN)

FDA grants accelerated approval to Tasigna nilotinib for first-line treatment of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in chronic phase