1Q approvals/1Q setbacks

1Q approvals/1Q setbacks

1Q approvals
Selected first quarter product approvals.
Company Approval
Abbott (NYSE:ABT) FDA approves Simcor, a fixed-dose combination of extended-release niacin and immediate-release simvastatin, to manage cholesterol in patients with complex lipid disease when treatment with either therapy alone is not adequate
Artisan/Asahi Kasei (Tokyo:3407) Japan approves ART-123 recombinant human thrombomodulin to treat disseminated intravascular coagulation (DIC) in sepsis
Bayer (Xetra:BAY)/Onyx (NASDAQ:ONXX) Japan approves Nexavar sorafenib to treat advanced renal cell carcinoma (RCC)
Biogen Idec (NASDAQ:BIIB)/ FDA approves Tysabri natalizumab to treat moderately to severely active Crohn's disease in patients who have
Elan (NYSE:ELN) had an inadequate response to, or are unable to tolerate, conventional therapies and inhibitors of TNF alpha
BioMarin (NASDAQ:BMRN; SWX:BMRN) Japan approves Naglazyme galsulfase to treat mucopolysaccharidosis VI (MPS VI)
Boehringer Ingelheim EC approves Pradaxa dabigatran etexilate to prevent venous thromboembolism after elective hip or knee replacement surgery
Cangene (TSX:CNJ) FDA approves Accretropin somatropin recombinant human growth hormone (rhGH) to treat growth failure in children with growth hormone deficiency and short stature associated with Turner's syndrome
Cephalon (NASDAQ:CEPH) FDA approves Treanda bendamustine to treat chronic lymphocytic leukemia (CLL)
Genentech (NYSE:DNA)/ FDA grants accelerated approval for Avastin bevacizumab plus paclitaxel to treat chemotherapy-naïve patients
Roche (SWX:ROG) with metastatic breast cancer
Jazz (NASDAQ:JAZZ)/Solvay (Euronext:SOLB) FDA approves Luvox CR to treat obsessive compulsive disorder (OCD) and social anxiety disorder (SAD)
Johnson & Johnson (NYSE:JNJ) FDA grants accelerated approval for

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