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FDA approves Seroquel for bipolar maintenance

The FDA has approved AstraZeneca’s Seroquel (quetiapine fumarate tablets) for the maintenance treatment of patients with bipolar I disorder, as adjunct therapy to lithium or divalproex.

OraVerse approved for dental anesthetic recovery

Novalar has received approval to market OraVerse (phentolamine mesylate injection) for the reversal of soft-tissue anesthesia and the associated functional deficits resulting from a local dental anesthetic.

NovoSeven RT approved to control surgical bleeding

The FDA has approved Novo Nordisk’s NovoSeven RT (recombinant human coagulation factor VIIa), another formulation of NovoSeven, that can be stored at room temperature (up to 81°F) for up to two years.

Generic Yasmin approved

Barr has received approval to market a generic version of Bayer’s oral contraceptive, Yasmin (drospirenone and ethinyl estradiol tablets).

FDA approves Taclonex Scalp for psoriasis

Warner Chilcott and LEO Pharma have received FDA approval for Taclonex Scalp (calcipotriene 0.005% and betamethasone dipropionate 0.064% topical suspension), a once-daily therapy for the treatment of moderate-to-severe psoriasis vulgaris of the scalp in adults.

Abilify gains expanded bipolar and schizophrenia indications

The FDA has approved Abilify (aripiprazole, from Bristol-Myers Squibb and Otsuka) for the maintenance treatment of manic and mixed episodes associated with bipolar I disorder, with or without psychotic features, in children 10-17 years of age and for the maintenance treatment of schizophrenia in adolescents 13-17 years of age.

FDA approves Strattera for ADHD maintenance

The FDA has approved Strattera (atomoxetine HCl capsules, from Eli Lilly) for maintenance treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children ≥6 years of age.