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FDA denies approval to expanded use of J&J/Bayer's Xarelto

2013-03-05 05:49:55| Food - Topix.net

Johnson & Johnson said health regulators denied approval to an expanded use of its blood thinner, Xarelto, to reduce the risk of heart attacks and strokes in patients with acute coronary syndrome.

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FDA panel votes against approval of Noven's menopause drug

2013-03-05 02:36:50| Biotech - Topix.net

A panel of advisors to the Food and Drug Administration recommended that the agency reject a drug for hot flashes associated with menopause made by Hisamitsu Pharmaceutical Co Inc's subsidiary Noven Pharmaceuticals Inc.

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Biotage: Food contact notification to FDA

2013-03-04 11:17:15| Appliances - Topix.net

Biotage AB through its subsidiary MIP Technologies AB submits Food Contact Notification to U.S. Food and Drug Administration Biotage acquired MIP Technologies in 2010 to gain access to world class development capabilities of custom designed molecular imprinted and other novel polymers.

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FDA approves once-monthly Abilify for schizophrenia

2013-03-01 04:10:30| Biotech - Topix.net

U.S. regulators on Thursday approved a once-monthly injectable form of Abilify, the blockbuster treatment for schizophrenia, which will be sold by Japanese drugmaker Otsuka and Danish drug group Lundbeck .

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Pernix Therapeutics Receives FDA Approvals

2013-02-28 10:00:00| foodingredientsonline News Articles

Pernix Therapeutics Holdings, Inc. (“Pernix” or the “Company”), a specialty pharmaceutical company, recently announced that its subsidiary, Hawthorn Pharmaceuticals, Inc., has received U.S. Food and Drug Administration (FDA) approval of a new drug application (NDA) for VITUZ® Oral Solution (hydrocodone bitartrate and chlorpheniramine maleate)

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