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12:00 AM
Apr 07, 2008
 |  BioCentury  |  Finance

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 Intelence etravirine (TMC125) to treat HIV-1 in antiretroviral treatment-experienced adult patients when used in combination with other antiretroviral agents
MiddleBrook (NASDAQ:MBRK) FDA approves once-daily Moxatag amoxicillin extended-release tablets to treat adults and adolescents aged 12 and over with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes
Speedel (SWX:SPPN)/Novartis FDA approves Tekturna HCT to treat hypertension. The drug is a single-tablet combination of the diuretic
(NYSE:NVS; SWX:NOVN) hydrochlorothiazide and aliskiren, a renin inhibitor marketed in the U.S. as Tekturna and in the EU as Rasilez.
Pfizer (NYSE:PFE) Japan approves Champix varenicline for smoking cessation
ProStrakan (LSE:PSK)/Orexo (SSE:ORX) Sweden approves Rapinyl fentanyl to treat breakthrough cancer pain
Regeneron (NASDAQ:REGN) FDA approves Arcalyst rilonacept to treat CIAS1-associated periodic syndrome (CAPS)
Spectrum (NASDAQ:SPPI) FDA approves injectable levoleucovorin levofolinic acid (formerly ISO-Vorin) to treat osteosarcoma after high-dose methotrexate therapy and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists
Wyeth (NYSE:WYE) FDA approves Xyntha antihemophilic factor to control and prevent bleeding in patients with hemophilia FDA approves Pristiq desvenlafaxine (DVS-233) to treat major depressive disorder (MDD)
ZymoGenetics (NASDAQ:ZGEN) FDA approves...

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