ions. Among race subgroups, there were no differences in the consistency of the crofelemer treatment effect except for the subgroup of African-Americans; crofelemer was less effective in African-Americans than non-African-Americans.
Although the CD4 cell count and HIV viral load did not appear to change over the one month placebo-controlled period, the clinical significance of this finding is unknown because of the short duration of the placebo-controlled period.
Of the 24 clinical responders to crofelemer (125 mg twice daily), 22 entered the placebo-free period; 16 were responding at the end of month 3, and 14 were responding at the end of month 5.
How is Fulyzaq Tablets Supplied
Crofelemer delayed-release tablets, 125 mg, are white, oval enteric-coated tablets printed on one side with 125SLXP. They are available in the following package size:
Bottles of 60: NDC 65649-802-02
Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C-30°C (59°F-86°F). See USP Controlled Room Temperature.
Patient Counseling Information
•Instruct patients that Fulyzaq Tablets may be taken with or without food.
•Instruct patients that FULYZAQtablets should not be crushed or chewed. Tablets should be swallowed whole.
Rx Only
Manufactured by Patheon, Inc. for
Salix Pharmaceuticals, Inc., Raleigh, NC 27615
Copyright © Salix Pharmaceuticals, Inc.
US Patent Nos. 7,341,744 and 7,323,195.
FULYZAQ is distributed by Salix Pharmaceuticals, Inc. under license from Napo Pharmaceuticals, Inc.
The botanical drug substance of FULYZAQ is extracted from Croton lechleri (the botanical raw material) that is harvested from the wild in South America.
PACKAGE LABEL - PRINCIPAL DISPLAY - FULYZAQ 125 mg Tablets, 60 Tablets Bottle Label
NDC 65649-802-02
FULYZAQ™
(crofelemer) 125 mg tablets
60 Tablets Unit Dose
Rx ONLY
FULYZAQ
crofelemer tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65649-802
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CROFELEMER (CROFELEMER) CROFELEMER 125 mg
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 16mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:65649-802-02 60 TABLET, COATED (60 TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202292 12/31/2012
Labeler - Salix Pharmaceuticals, Inc. (793108036)
Revised: 02/2013
