FDA actions in brief, January 2008


FDA-related information through January 2008 for sorafenib (Nexavar), aripiprazole (Abilify), rosuvastatin (Crestor), irbesartan/hydrochlorothiazide (Avalide), extended-release quetiapine (Seroquel XL), delayed-release oral suspension of pantoprazole (Protonix), lopinavir/ritonavir (Kaletra), and dasatinib (Sprycel)

Key Points

Sorafenib (Nexavar, Bayer/Onyx) was approved for the treatment of unresectable hepatocellular carcinoma.

Aripiprazole (Abilify, Otsuka/Bristol-Myers Squibb) was approved for the treatment of schizophrenia in adolescent patients aged 13 to 17 years and as adjunctive treatment to antidepressant therapy in adult patients with major depressive disorder.

Rosuvastatin (Crestor, AstraZeneca) was approved as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol levels.

FDA approved an extended-release formulation of quetiapine (Seroquel XR, AstraZeneca) for the once-daily maintenance treatment of schizophrenia in adult patients.

A delayed-release oral suspension of pantoprazole (Protonix, Wyeth) was approved for the treatment and maintenance of healing of erosive esophagitis with associated gastro-esophageal reflux disease symptoms.

A lower-strength tablet formulation of lopinavir/ritonavir (Kaletra, Abbott) was approved for use in combination with other anti-HIV-1 agents for the treatment of HIV-1 infection in patients aged ≥6 months.

The labeling for dasatinib (Sprycel, Bristol-Myers Squibb) was updated to include a recommended starting dose of 100 mg once daily for the treatment of patients with chronic-phase chronic myeloid leukemia resistant or intolerant to prior therapy.

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