Expanded Indications/Labeling Changes for May 2008

[chantell.reagan]

New Formulations/Expanded Indications/Labeling Changes for May 2008:

New Formulations/Dosage Regimens:

Sprycel (dasatinib): new tablet strength 100mg film coated tablets

• Letter from FDA: Letter from FDA

• Prescribing information: Prescribing information

Mesalamine (tradename to be determined): new 800mg delayed release tablet

• Letter from FDA: Letter from FDA

Venlafaxine: new formulation 225mg extended release tablet

• Letter from FDA: Letter from FDA

Abilify (aripiprazole): expanded indications: adjunctive therapy to either lithium or valproate for the treatment of manic and mixed episodes associated with bipolar I disorder in adults and pediatric patients aged 10 to 17 years. Use of aripiprazole for this indication previously was limited to monotherapy

• Letter from FDA: Letter from FDA

• Prescribing information: Prescribing information

Chantix (lubiprostone): new warning: neuropsychiatric symptoms; d/c if agitation, depressed mood, or changes in behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior

• Letter from FDA: Letter from FDA

• Prescribing information: Prescribing information

Levaquin (levofloxacin): expanded indication: treatment of inhalational anthrax (postexposure) in children

• Letter from FDA: Letter from FDA

• Prescribing information: Prescribing information

Levitra (levofloxacin): post-marketing section update (neurologic subsection): addition of the term “transient global amnesia”

• Letter from FDA: Letter from FDA

• Prescribing information: Prescribing information

Seroquel/XR (quetiapine): expanded indication: maintenance treatment for bipolar I disorder, as adjunctive therapy to lithium or divalproex

• Letter from FDA: Letter from FDA

• Prescribing information: Prescribing information

Strattera (atomoxetine hydrochloride): expanded indication: maintenance treatment of attention-deficit hyperactivity disorder (ADHD) in children and adolescents

• Letter from FDA: Letter from FDA

• Prescribing information: Prescribing information

Sources:

U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA