Lutein

Overview

Lutein is an xanthophyll and one of 600 known naturally occurring carotenoids. Lutein is synthesized only by plants and like other xanthophylls is found in high quantities in green leafy vegetables such as spinach, kale and yellow carrots. In green plants, xanthophylls act to modulate light energy and serve as non-photochemical quenching agents to deal with triplet chlorophyll (an excited form of chlorophyll), which is overproduced at very high light levels, during photosynthesis.

Indication

Xanthophylls are taken for nutritional supplementation, and also for treating dietary shortage or imbalance.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Effects of Lutein Supplementation on Oxidative Stress and Inflammation in Healthy Nonsmokers	2010/01/26	NCT01056094	Phase 1	UNKNOWN	Peking University
Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration	2010/01/13	NCT01048476	Phase 1	UNKNOWN	Peking University
"Visiobiane Anti-age" Effects on Vision Parameters	2007/03/21	NCT00449917	Phase 4	Completed	PiLeJe
Clinical Trial of Lutein for Patients With Retinitis Pigmentosa Receiving Vitamin A	2006/06/29	NCT00346333	Phase 3	Completed	National Eye Institute (NEI)
Lutein/Zeaxanthin and Omega-3 Supplementation in Persons Over Age 60	2005/07/21	NCT00121589	Phase 1	Completed	National Eye Institute (NEI)
Effects of Lutein in Retinitis Pigmentosa	2002/01/10	NCT00029289	Phase 1	Completed	National Center for Complementary and Integrative Health (NCCIH)
Lutein for Age-Related Macular Degeneration	2000/09/11	NCT00006202	Phase 2	Completed	National Eye Institute (NEI)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Strovite One Caplets	Exeltis USA, Inc.	0642-0207	ORAL	5 mg in 1 1	1/2/2023
Ocuvel	Adler-Stern Pharmaceuticals, LLC	69054-210	ORAL	10 mg in 1 1	11/7/2014
Ocuvel	Adler-Stern Pharmaceuticals, LLC	69054-211	ORAL	5 mg in 1 1	12/2/2014

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Macutec Essentials	326524	Stiltec Pty Ltd	Medicine	A	11/22/2019
Kids Multi	329564	Factors Group Australia Pty Ltd	Medicine	A	2/6/2020
BLACKMORES MACU-VISION PLUS	317969	Blackmores Ltd	Medicine	A	5/28/2019
NUTRA-LIFE BILBERRY 10,000 PLUS	310442	Vitaco Health Australia Pty Ltd	Medicine	A	10/17/2018
Swisse Men's Multivitamins	351919	Swisse Wellness Pty Ltd	Medicine	A	12/18/2020
USANA HealthPak	350153	Usana Australia Pty Ltd	Medicine	A	11/30/2020
Daily Multi Multivitamin	337216	Jamieson Health Products Australia Pty Ltd	Medicine	A	5/29/2020
HK-SG Swisse Kids Eye Health	349251	Swisse Wellness Pty Ltd	Medicine	A	11/23/2020
Eye Vita Plus	379094	Jmm International Pty Ltd	Medicine	A	11/26/2021
Optimal Omega +	396614	Eimele Pty Ltd	Medicine	A	9/28/2022

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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