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).
Axcan has launched Canasa Pac, a single prescription pack of forty-two Canasa (mesalamine) 1000mg rectal suppositories in addition to the 30 pack already available.
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.
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.
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.
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.
The FDA has approved Humira (adalimumab, from Abbott) for the treatment of juvenile rheumatoid arthritis (JRA).
Atralin (tretinoin) gel 0.05%, a topical retinoid, has been made available by Coria Laboratories for the treatment of acne vulgaris.
Sciele Pharma has launched Fenoglide (fenofibrate) 40mg and 120mg tablets for the treatment of hyperlipidemia and hypertriglyceridemia.