Attached files

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EXCEL - IDEA: XBRL DOCUMENT - AVANIR PHARMACEUTICALS, INC.Financial_Report.xls
EX-10.38 - EX-10.38 - AVANIR PHARMACEUTICALS, INC.d782149dex1038.htm
EX-10.24 - EX-10.24 - AVANIR PHARMACEUTICALS, INC.d782149dex1024.htm
EX-10.22 - EX-10.22 - AVANIR PHARMACEUTICALS, INC.d782149dex1022.htm
EX-32.1 - EX-32.1 - AVANIR PHARMACEUTICALS, INC.d782149dex321.htm
EX-31.1 - EX-31.1 - AVANIR PHARMACEUTICALS, INC.d782149dex311.htm
EX-10.17 - EX-10.17 - AVANIR PHARMACEUTICALS, INC.d782149dex1017.htm
EX-32.2 - EX-32.2 - AVANIR PHARMACEUTICALS, INC.d782149dex322.htm
EX-23.1 - EX-23.1 - AVANIR PHARMACEUTICALS, INC.d782149dex231.htm
EX-31.2 - EX-31.2 - AVANIR PHARMACEUTICALS, INC.d782149dex312.htm
EX-10.23 - EX-10.23 - AVANIR PHARMACEUTICALS, INC.d782149dex1023.htm
EX-10.40 - EX-10.40 - AVANIR PHARMACEUTICALS, INC.d782149dex1040.htm
EX-10.41 - EX-10.41 - AVANIR PHARMACEUTICALS, INC.d782149dex1041.htm
EX-10.39 - EX-10.39 - AVANIR PHARMACEUTICALS, INC.d782149dex1039.htm
10-K - 10-K - AVANIR PHARMACEUTICALS, INC.d782149d10k.htm
EX-10.37 - EX-10.37 - AVANIR PHARMACEUTICALS, INC.d782149dex1037.htm

Exhibit 99.1

NUEDEXTA Safety Information

NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state.

Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer’s disease and other dementias.

NUEDEXTA and certain other medicines can interact, causing serious side effects. If you take certain drugs or have certain heart problems, NUEDEXTA may not be right for you.

NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation should be conducted at baseline and 3-4 hours after the first dose.

The most common adverse reactions are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence. NUEDEXTA may cause dizziness.

These are not all the risks from use of NUEDEXTA. Please refer to full Prescribing Information at www.NUEDEXTA.com.