recent recommendations for approval from japan's cpac

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Inpharma 1254 - 9 Sep 2000 Recent recommendations for approval from Japan’s CPAC The Japanese Central Pharmaceutical Affairs Council (CPAC) has recently recommended a number of products for approval, reports Scrip. These products include: protein C [‘Anact’; Kaketsuken] for the treatment of disseminated intravascular coagulopathy and thrombosis caused by congenital protein C deficiency Schering AG’s interferon-β-1b [‘Betaferon’] for the treatment of multiple sclerosis the hypnotic zolpidem [‘Myslee’; Sanofi- Synth´ elabo, Fujisawa] for the treatment of insomnia paroxetine [‘Paxil’; SmithKline Beecham] for the treatment of depression and panic disorder Novartis’ angiotensin II receptor antagonist valsartan [‘Diovan’] for the treatment of hypertension fexofenadine [‘Allegra’; Aventis, Sepracor] for the treatment of allergic rhinitis and urticaria ophthalmic acitazanolast [‘Zepelin’; Wakamoto, Kowa] for the treatment of allergic conjunctivitis. Approval recommendations in Japan. Scrip : 20, No. 2569, 25 Aug 2000 800839303 1 Inpharma 9 Sep 2000 No. 1254 1173-8324/10/1254-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Inpharma 1254 - 9 Sep 2000

Recent recommendations forapproval from Japan’s CPAC

The Japanese Central Pharmaceutical Affairs Council(CPAC) has recently recommended a number ofproducts for approval, reports Scrip.

These products include:• protein C [‘Anact’; Kaketsuken] for the treatment of

disseminated intravascular coagulopathy andthrombosis caused by congenital protein Cdeficiency

• Schering AG’s interferon-β-1b [‘Betaferon’] for thetreatment of multiple sclerosis

• the hypnotic zolpidem [‘Myslee’; Sanofi-Synthelabo, Fujisawa] for the treatment of insomnia

• paroxetine [‘Paxil’; SmithKline Beecham] for thetreatment of depression and panic disorder

• Novartis’ angiotensin II receptor antagonistvalsartan [‘Diovan’] for the treatment ofhypertension

• fexofenadine [‘Allegra’; Aventis, Sepracor] for thetreatment of allergic rhinitis and urticaria

• ophthalmic acitazanolast [‘Zepelin’; Wakamoto,Kowa] for the treatment of allergic conjunctivitis.

Approval recommendations in Japan. Scrip : 20, No. 2569, 25 Aug2000 800839303

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Inpharma 9 Sep 2000 No. 12541173-8324/10/1254-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved