( cytarabine liposome injection) For Intrathecal Use Only Initial U.S. Approval: <START:fdaapprovaldate> 1999 <END> WARNING: CHEMICAL ARACHNOIDITIS ADVERSE REACTIONS See full prescribing information for complete
 ( pegfilgrastim ) injection, for subcutaneous use Initial U.S. Approval: <START:fdaapprovaldate> 2002 <END> RECENT MAJOR CHANGES &#x2022; Dosage and Administration (2.3 and 2.4) 12/2014
RAPAMUNE ( sirolimus ) ORAL SOLUTION AND TABLETS Initial U.S. Approval: <START:fdaapprovaldate> 1999 <END> WARNING: IMMUNOSUPPRESSION, USE IS NOT RECOMMENDED IN LIVER OR LUNG TRANSPLANT
( sevelamer hydrochloride ) Tablet for Oral use Initial U.S. Approval: <START:fdaapprovaldate> 2000 <END> INDICATIONS AND USAGE &#x2022; Renagel  is a phosphate binder indicated
. MACUGEN ( pegaptanib sodium injection) Intravitreal Injection Initial U.S. Approval: <START:fdaapprovaldate> 2004 <END> INDICATIONS AND USAGE Macugen is indicated for the treatment of neovascular
TRIGLIDE ( fenofibrate ) Tablets, for oral use Initial U.S. Approval: <START:fdaapprovaldate> 1993 <END> INDICATIONS AND USAGE Triglide is a peroxisome proliferator receptor alpha (PPARα)
 ( estradiol topical emulsion) for topical use Initial U.S. Approval: <START:fdaapprovaldate> 1975 <END> WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA See
( ibritumomab tiuxetan ) Injection for intravenous use Initial U.S. Approval: <START:fdaapprovaldate> 2002 <END> WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS
ES ( megestrol acetate , USP) Oral Suspension Initial U.S. Approval: <START:fdaapprovaldate> 1993 <END> INDICATIONS AND USAGE Megace  ES oral suspension is a progestin
( pegvisomant ) for injection, for subcutaneous use Initial U.S. Approval: <START:fdaapprovaldate> 2003 <END> RECENT MAJOR CHANGES Warnings and Precautions, Systemic Hypersensitivity (5.5) 6/2012 INDICATIONS
) Injection Concentrate, Intravenous Infusion ( IV ). Initial U.S. Approval: <START:fdaapprovaldate> 1996 <END> WARNING: TOXIC DEATHS , HEPATOTOXICITY , NEUTROPENIA , HYPERSENSITIVITY REACTIONS ,
. Venofer  ( iron sucrose injection, USP) Initial U.S. Approval: <START:fdaapprovaldate> 2000 <END> RECENT MAJOR CHANGES &#x2022; Indications and Usage (1) 9/2012 &#x2022; Dosage
for Injection: Intravenous [IV] or Subcutaneous [SC] use Initial U.S. Approval: <START:fdaapprovaldate> 2007 <END> WARNINGS: ESAs INCREASE THE RISK OF DEATH , MYOCARDIAL INFARCTION ,
( peginterferon alfa-2b ) injection, for subcutaneous use Initial U.S. Approval: <START:fdaapprovaldate> 2001 <END> WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN -ASSOCIATED EFFECTS See full
( peginterferon alfa-2a ) injection, for subcutaneous use Initial U.S. Approval: <START:fdaapprovaldate> 2002 <END> WARNING: RISK OF SERIOUS DISORDERS See full prescribing information for complete
 LIPOSOME injection). Marqibo ( vinCRIStinesulfate  LIPOSOME injection)for intravenous infusionInitialU.S.Approval: <START:fdaapprovaldate> 2012 <END>  WARNINGSee full prescribing information for complete boxed warning. x For
COPAXONE ( glatiramer acetate injection) for subcutaneous use Initial U.S. Approval: <START:fdaapprovaldate> 1996 <END> RECENT MAJOR CHANGES Dosage and Administration, Recommend Dose (2.1) 01/2014 Dosage
fosaprepitant dimeglumine ) for Injection, for intravenous use Initial U.S. Approval: <START:fdaapprovaldate> 2008 <END> INDICATIONS AND USAGE  EMEND  for Injection is a substance
I 131 tositumomab ) Injection, for intravenous infusion Initial U.S. Approval: <START:fdaapprovaldate> 2003 <END> WARNING: SERIOUS ALLERGIC REACTIONS/ANAPHYLAXIS, PROLONGED AND SEVERE CYTOPENIAS, AND RADIATION EXPOSURE
complex in sucrose injection), For intravenous (IV) use Initial U.S. Approval: <START:fdaapprovaldate> 1999 <END> RECENT MAJOR CHANGES Warnings and Precautions, Hypersensitivity (5.1) 08/2011 Warnings and
 ( pegloticase ) Injection, for intravenous infusion Initial U.S. Approval: <START:fdaapprovaldate> 2010 <END> WARNING: ANAPHYLAXIS and INFUSION REACTIONS See full prescribing information for complete
( paclitaxel protein-bound particles for injectable suspension) (albumin-bound) Initial U.S. Approval: <START:fdaapprovaldate> 2005 <END> WARNING: NEUTROPENIA See full prescribing information for complete boxed warning. &#x201a;
gel) 0.06% 0.52 mg of estradiol per actuation Initial U.S. Approval: <START:fdaapprovaldate> 1975 <END> WARNING: ENDOMETRIAL CANCER , CARDIOVASCULAR DISORDERS , BREAST CANCER and PROBABLE
brentuximab vedotin ) for injection, for intravenous use Initial U.S. approval: <START:fdaapprovaldate> 2011 <END> WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) See full prescribing information for complete
DEPOT . SOMATULINE DEPOT ( lanreotide ) INJECTION Initial U.S. Approval: <START:fdaapprovaldate> 2007 <END> RECENT MAJOR CHANGES Indications and Usage Gastroenteropancreatic Neuroendocrine Tumors (1.2) 12/2014
( ferumoxytol ) Injection For Intravenous (IV) use Initial U.S. Approval: <START:fdaapprovaldate> 2009 <END> RECENT MAJOR CHANGES Boxed Warning 03/2015 Dosage and Administration (2) 03/2015
pegaspargase ) injection, for intramuscular or intravenous use Initial U.S. Approval: <START:fdaapprovaldate> 1994 <END> RECENT MAJOR CHANGES Warnings and Precautions (5.6) 04/2014 INDICATIONS AND USAGE
TRICOR ( fenofibrate ) Tablet, for oral use Initial U.S. Approval: <START:fdaapprovaldate> 1993 <END> INDICATIONS AND USAGE  TRICOR is a peroxisome proliferator receptor alpha
for WELCHOL . WELCHOL ( colesevelam hydrochloride ) Initial U.S. Approval: <START:fdaapprovaldate> 2000 <END> RECENT MAJOR CHANGES Warnings and Precautions (5.6) 5/2013 INDICATIONS AND USAGE
San Francisco, CA 94080-4990 U.S. License No: 1048 Initial U.S. Approval: <START:fdaapprovaldate> February 2013 <END> KADCYLA is a trademark of Genentech, Inc. 2015 Genentech, Inc. </TextWithNodes>
ado-trastuzumab emtansine ) for injection, for intravenous use Initial U.S. Approval: <START:fdaapprovaldate> 2013 <END> RECENT MAJOR CHANGES Dosage and Administration (2.3) 05/2015 Warnings and Precautions
( doxorubicin hydrochloride liposome injection), for intravenous use Initial U.S. Approval: <START:fdaapprovaldate> 1995 <END> WARNING: CARDIOMYOPATHY and INFUSIONRELATED REACTIONS See full prescribing information for complete
