FDA actions in brief, July 2008 (Abilify, Levaquin, Taclonex Scalp, Recothrom, Seroquel)

Recent FDA approvals and indications (through July 2008) related to Abilify, Levaquin, Taclonex Scalp, Recothrom, and Seroquel.

Aripiprazole (Abilify, Bristol-Myers Squibb/Otsuka) was approved as an adjunctive therapy to lithium or valproate for the acute treatment of manic and mixed episodes associated with bipolar I disorder with or without psychotic features in adults and in patients aged 10 to 17 years. This agent was also approved as maintenance treatment of manic and mixed episodes associated with bipolar I disorder with or without psychotic features in patients aged 10 to 17 years and as maintenance treatment of schizophrenia in patients aged 13 to 17 years. A new starting and target dose (15 mg/d) of aripiprazole as monotherapy was also approved for the treatment of bipolar I disorder in adults.

Levofloxacin (Levaquin, Ortho-McNeil) was approved for the treatment of patients aged >6 months who are exposed to inhaled anthrax. Quetiapine (Seroquel, AstraZeneca) was approved for the maintenance treatment of patients with bipolar I disorder as an adjunct to lithium or divalproex.

Calcipotriene 0.005%/betamethasone dipropionate 0.064% topical suspension (Taclonex Scalp, Warner Chilcott/LEO Pharma) was approved for the treatment of moderate-to-severe psoriasis vulgaris of the scalp in adults.