The Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Triglide (fenofibrate; Shionogi, Inc.) to include additional Patient Counseling Information in the package insert.
The following information will now be included under the “Patients should be advised” section in the package insert:
- Triglide must be kept in the original bottle to protect from moisture. The bottle contains a desiccant in the cap to protect tablets from moisture.
- Tablets should not be stored or placed in any other container, such as pill boxes or pill organizers.
- Chipped or broken tablets should not be taken.
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Triglide is indicated as adjunct to diet in hypertriglyceridemia (Types IV and V), to reduce elevated total-C, LDL-C, apo B, TG, and to increase HDL-C in primary hypercholesterolemia and mixed dyslipidemia (Types IIa and IIb) in adults. It is available as 160mg tablets.
For more information visit FDA.gov.
