R&D
Table 1: Japanese new chemical entity approvals*
Product Generic name Indication Company
Actemra tocilizumab rheumatoid arthritis
1,2
Chugai/Roche
Amerge naratriptan migraine GlaxoSmithKline
Aroglycem diazoxide hyperinsulinism Schering-Plough
Champix varenicline smoking cessation Pfizer
Clexane enoxaparin venous thrombo-embolism (orthopaedic) Sanofi-Aventis
Differin adapalene acne Galderma
Erbitux cetuximab colorectal cancer
2
ImClone/BMS/Merck KGaA
Exjade deferasirox iron overload Novartis
Famvir famciclovir herpes Asahi Kasei
Fosrenol lanthanum hyperphosphataemia Bayer Schering
Ganirest ganirelix in vitro fertilisation Schering-Plough
Gracevit sitafloxacin infections Daiichi Sankyo
Humira adalimumab rheumatoid arthritis Abbott
Inoflo nitric oxide infant hypoxic respiratory failure Ino Therapeutics
Irbetan/Avapro irbesartan hypertension Shionogi/DSP
Irribow ramosetron
3
male irritable bowel syndrome Astellas
Isentress raltegravir HIV-1
2
Merck & Co
Julina estradiol climacteric syndrome/ovarian Bayer Schering
deficiency, postmenopausal osteoporosis
Lamictal lamotrigine epilepsy GlaxoSmithKline
Lonasen blonanserin schizophrenia Dainippon-Sumitomo
Lunabell norethisterone plus dysmenorrhoea Nobel Pharma
ethinylestradiol
Macugen pegaptanib wet age-related macular degeneration
2
Pfizer
Mycobutin rifabutin tuberculosis/Mycobacterium Pfizer
avium complex in HIV
Naglazyme galsulfase mucopolysaccharidosis
2
AnGes MG
Nexavar sorafenib renal cell carcinoma (RCC)
2
Bayer Schering
Nobelbar phenobarbital neonatal seizures Nobel Pharma
Nobelzin zinc acetate Wilson’s disease
2
Nobel Pharma
Pirespa pirfenidone pulmonary fibrosis Shionogi
Prezista darunavir HIV/AIDS
2
Janssen
Revatio sildenafil pulmonary arterial hypertension
2
Pfizer
Ricomodulin ART-123 disseminated intravascular coagulation Asahi Kasei
Sutent sunitinib RCC/resistant gastrointestinal stromal tumours
2
Pfizer
Talimus tacrolimus eye spring catarrh
2
Senju
Tapros tafluprost glaucoma/ocular hypertension Santen
Thymo-globulin rabbit globulin hypoplastic anaemia
2
Sanofi-Aventis
Wellnara estradiol plus postmenopausal osteoporosis Bayer Schering
levonorgestrel
Zevalin ibritumomab non-Hodgkin’s lymphoma/mantle cell lymphoma
2
Bayer Schering
Zosyn tazobactam plus piperacillin pneumonia etc Taiho/Toyama
Note: originators, licensors and alternative brand names not shown;
1
previously approved for Castleman’s disease;
2
orphan indication;
3
already marketed as an anti-emetic.
* products listed alphabetically, year to October 31st, 2008
www.scripnews.com/supplements Scrip 100
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