Expanded Indications/Labeling Changes for February 2008:

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Expanded Indications/Labeling Changes for February 2008:

New Formulations/Dosage Regimens:

Prezista (darunavir): 600 mg tablet strength formulation available

• Letter from FDA: Letter from FDA

• Prescribing information: Prescribing information

Xopenex HFA (levalbuterol tartrate): 45 mcg per actuation with 80 actuations

• Letter from FDA: Letter from FDA

• Prescribing information: Prescribing information

Expanded Indications/Dosage Regimens:

Aloxi (palonosetron hydrochloride): new indication: Prevention of postoperative nausea and vomiting for up to 24 hours following surgery; in addition, QT safety label information removed

• Letter from FDA: Letter from FDA

• Prescribing information: Prescribing information

Abilify (aripiprazole): new indication: Treatment of acute manic or mixed episodes associated with bipolar I disorder as monotherapy or adjunctive (e.g., lithium or valproate) in pediatric patients (10-17 years of age)

• Letter from FDA: Letter from FDA

• Prescribing information: Prescribing information

Nexium (esomeprazole magnesium): new indication and new dosage regimen: Short-term treatment of GERD and healing of erosive esophagitis in pediatric patients (1-11 years of age) (for delayed-release oral suspension 10 mg); new dosing schedule for pediatric patients

• Letter from FDA: Letter from FDA

• Prescribing information: Prescribing information

Humira (adalimumab): new indication: Management of moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older; now available in a 20 mg pre-filled syringe

• Letter from FDA: Letter from FDA

• Prescribing information: Prescribing information

Avastin (bevacizumab): new indication: Treatment of patients who have not received chemotherapy for metastatic HER2 negative breast cancer in combination with paclitaxel

• Letter from FDA: Letter from FDA

• Prescribing information:Prescribing information

Sources:
Caremark TrendsRx® Drug Pipeline and News. Available at: https://www.caremark.com/portal/asset/DPN_Feb_2008.pdf
U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA