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The FDA has approved Nexium Delayed-Release (esomeprazole magnesium, from AstraZeneca) 10mg oral suspension for the short-term treatment of gastroesophageal reflux disease (GERD) in patients 1-11 years of age.

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The FDA is warning healthcare providers of reported hepatic injury associated with Tysabri (natalizumab, from Biogen Idec).

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Hisamitsu has received FDA approval for Salonpas Pain Relief Patch (methyl salicylate and l-menthol) for the temporary relief of mild-to-moderate aches and pains of muscles and joints associated with arthritis, sprains, bruises and simple backache.

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The FDA has granted Genentech accelerated approval for Avastin (bevacizumab), in combination with paclitaxel, for the treatment of metastatic HER2-negative breast cancer in chemotherapy-naïve patients.

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Sciele Pharma will market Allegra (fexofenadine HCl) orally disintegrating tablets (ODT) for the relief of seasonal allergy symptoms and chronic idiopathic urticaria (CIU) in children 6-11 years of age.

Xyntha approved for hemophilia A
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The FDA has approved Wyeth’s Xyntha (recombinant antihemophilic factor VIII) for both the control and prevention of bleeding episodes and surgical prophylaxis in patients with hemophilia A.

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The FDA has approved Humira (adalimumab, from Abbott) for the treatment of juvenile rheumatoid arthritis (JRA).

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Atralin (tretinoin) gel 0.05%, a topical retinoid, has been made available by Coria Laboratories for the treatment of acne vulgaris.