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1. Omacor
2. Omega-3 Ethyl Ester 90
3. P-om3 Adjunct
1. 861006-80-6
2. Omacor
3. Coromega
4. Lotriga
5. Zodin
6. Ethyl (4z,7z,10z,13z,16z,19z)-docosa-4,7,10,13,16,19-hexaenoate Compound With Ethyl (5z,8z,11z,14z,17z)-icosa-5,8,11,14,17-pentaenoate (1:1)
7. Omega-3 Acid Ethyl Esters
8. Omega-3-acid Ethyl Ester
9. Omega-3-acid Ethyl Esters
10. Chembl1200711
11. Tak-085
12. Omega-3-acid Ethyl Esters Type A
13. Icosapent (epa Ethyl Ester)
14. Doconexent (dha Ethyl Ester)
15. K-85
16. 4,7,10,13,16,19-docosahexaenoic Acid, Ethyl Ester, (4z,7z,10z,13z,16z,19z)-, Mixt. With (5z,8z,11z,14z,17z)-ethyl 5,8,11,14,17-eicosapentaenoate
17. Ethyl (4z,7z,10z,13z,16z,19z)-docosa-4,7,10,13,16,19-hexaenoate;ethyl (5z,8z,11z,14z,17z)-icosa-5,8,11,14,17-pentaenoate
Molecular Weight | 687.0 g/mol |
---|---|
Molecular Formula | C46H70O4 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 31 |
Exact Mass | 686.52741071 g/mol |
Monoisotopic Mass | 686.52741071 g/mol |
Topological Polar Surface Area | 52.6 Ų |
Heavy Atom Count | 50 |
Formal Charge | 0 |
Complexity | 916 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 11 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 4 | |
---|---|
Drug Name | Lovaza |
Drug Label | LOVAZA, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of LOVAZA contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a... |
Active Ingredient | Omega-3-acid ethyl esters |
Dosage Form | Capsule |
Route | Oral |
Strength | 1gm contains at least 900mg of the ethyl esters of omega-3 fatty acids |
Market Status | Prescription |
Company | Smithkline Beecham |
2 of 4 | |
---|---|
Drug Name | Omega-3-acid ethyl esters |
Drug Label | LOVAZA, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of LOVAZA contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a... |
Active Ingredient | Omega-3-acid ethyl esters |
Dosage Form | Capsule |
Route | Oral |
Strength | 1gm contains at least 900mg of the ethyl esters of omega-3 fatty acids |
Market Status | Prescription |
Company | Apotex; Teva Pharms Usa; Par Pharm |
3 of 4 | |
---|---|
Drug Name | Lovaza |
Drug Label | LOVAZA, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of LOVAZA contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a... |
Active Ingredient | Omega-3-acid ethyl esters |
Dosage Form | Capsule |
Route | Oral |
Strength | 1gm contains at least 900mg of the ethyl esters of omega-3 fatty acids |
Market Status | Prescription |
Company | Smithkline Beecham |
4 of 4 | |
---|---|
Drug Name | Omega-3-acid ethyl esters |
Drug Label | LOVAZA, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of LOVAZA contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a... |
Active Ingredient | Omega-3-acid ethyl esters |
Dosage Form | Capsule |
Route | Oral |
Strength | 1gm contains at least 900mg of the ethyl esters of omega-3 fatty acids |
Market Status | Prescription |
Company | Apotex; Teva Pharms Usa; Par Pharm |
Omega-3-Acid Ethyl Esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (500 mg/dL) hypertriglyceridemia (HTG).
FDA Label
Omega-3-acid ethyl esters reduce triglyceride production, increase fatty acid metabolism, inhibit the release of fatty acids, increase triglyceride clearance, and decrease production of very low density lipoprotein cholesterol(VLDL-C).
Absorption
Omega-3-acid ethyl esters are rapidly hydrolysed to free fatty acids in the intestinal lumen which then become incorporated into phospholipids, cholesterol, and triglycerides so determination of bioavailability by serum concentration is not possible.
Route of Elimination
Includes oxidative catabolism to carbon dioxide and water
Volume of Distribution
82 56L
Clearance
757 mL/h 283mL/h.
Omega-3-acid ethyl esters are hydrolysed to free fatty acids in the intestinal lumen by pancreatic lipase. Once in enterocytes, the free fatty acids are packaged in chylomicrons which are released from cells into the circulation. Fatty acids then enter the liver where they can be incorporated into liver stores, incorporated into lipoprotein phospholipids, or oxidised for energy.
79 hours 47 hours.
Omega-3-acid ethyl esters reduce triglyceride production by the liver but this mechanism is not well understood. Omega-3-acid ethyl esters inhibit acyl-CoA:1,2-diacylglycerol acyltransferase, reducing triglyceride synthesis and increasing paroxysmal beta-oxidation, which increases fatty aside metabolism. Omega-3-acid ethyl esters also inhibit the release of fatty acids by competing for enzymes involved in the synthesis of triglycerides, increase triglyceride clearance by increasing the activity of lipoprotein lipase, and decrease production of VLDL-C.
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-13
Pay. Date : 2013-01-22
DMF Number : 23369
Submission : 2010-01-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2013-12-16
DMF Number : 26056
Submission : 2012-08-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23510
Submission : 2010-04-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14685
Submission : 2000-01-26
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-28
Pay. Date : 2013-11-06
DMF Number : 25342
Submission : 2011-09-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-13
Pay. Date : 2021-02-03
DMF Number : 22106
Submission : 2008-10-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26559
Submission : 2012-10-15
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-31
Pay. Date : 2013-10-21
DMF Number : 22285
Submission : 2008-10-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22284
Submission : 2008-11-03
Status : Inactive
Type : II
Omega-3-acid ethyl esters 90, Code K85EE - containing alpha tocopherol as antioxidant
Certificate Number : R1-CEP 2008-132 - Rev 04
Status : Valid
Issue Date : 2020-01-21
Type : Chemical
Substance Number : 1250
Omega-3-acid ethyl esters 90, Code 03 K85EE - containing alpha tocopherol as antioxidant
Certificate Number : R1-CEP 2008-330 - Rev 04
Status : Valid
Issue Date : 2020-01-21
Type : Chemical
Substance Number : 1250
Certificate Number : R1-CEP 2014-182 - Rev 00
Status : Valid
Issue Date : 2021-02-09
Type : Chemical
Substance Number : 1250
Omega-3-acid ethyl esters 90, RF08200, with mixed tocopherols
Certificate Number : R1-CEP 2015-267 - Rev 00
Status : Valid
Issue Date : 2020-10-26
Type : Chemical
Substance Number : 1250
Omega-3-acid ethyl esters 90, Grade RF07800, with tocopherols
Certificate Number : R1-CEP 2015-057 - Rev 00
Status : Valid
Issue Date : 2020-07-16
Type : Chemical
Substance Number : 1250
Omega-3-acid ethyl esters 90, with antioxidant α-tocopherol
Certificate Number : R1-CEP 2010-230 - Rev 01
Status : Valid
Issue Date : 2017-08-23
Type : Chemical
Substance Number : 1250
Omega-3-acid ethyl esters 90, with α-tocopherol
Certificate Number : R0-CEP 2012-244 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2013-10-23
Type : Chemical
Substance Number : 1250
Omega-3-acid ethyl esters 60, Containing mixed tocopherols
Certificate Number : R1-CEP 2009-326 - Rev 01
Status : Valid
Issue Date : 2016-03-03
Type : Chemical
Substance Number : 2063
Omega-3-acid ethyl esters 60, Containing alpha tocopherol
Certificate Number : R1-CEP 2007-042 - Rev 00
Status : Valid
Issue Date : 2015-12-14
Type : Chemical
Substance Number : 2063
Omega-3-acid ethyl esters 90, with alpha-tocopherol
Certificate Number : R1-CEP 2014-064 - Rev 01
Status : Valid
Issue Date : 2021-12-06
Type : Chemical
Substance Number : 1250
Registration Number : 303MF10032
Registrant's Address : #81, Sanggae-Ro, Nam-Gu, Ulsan, Korea
Initial Date of Registration : 2021-02-16
Latest Date of Registration : 2021-02-16
Registration Number : 223MF10051
Registrant's Address : Lilleakerveien 2B, NO-0283 Oslo, Norway P. O. Box 420, NO-1327 Lysaker, Norway
Initial Date of Registration : 2011-04-12
Latest Date of Registration : 2021-02-10
Omega-3-Fatty Acid Ethyl Esters 90
Registration Number : 302MF10071
Registrant's Address : Cowick Hall, Snaith, Google, East Yorkshire, DN14 9AA, England
Initial Date of Registration : 2020-06-26
Latest Date of Registration : 2020-06-26
Omega-3 fatty acid ethyl esters
Registration Number : 304MF10004
Registrant's Address : Am Kraftwerk 6,66450 Bexbach, Germany
Initial Date of Registration : 2022-01-11
Latest Date of Registration : 2022-01-11
Registrant Name : Aekyung Biopharm Co., Ltd.
Registration Date : 2018-07-17
Registration Number : 6148-1-ND
Manufacturer Name : Aekyung Biopharm Co., Ltd.
Manufacturer Address : 81 Sanggae-ro, Nam-gu, Ulsan Metropolitan City (80, 80A)
Registrant Name : YuYu Pharmaceutical Co., Ltd.
Registration Date : 2023-09-21
Registration Number : No. 69-7-ND(5)
Manufacturer Name : Huatai Biopharm Inc.
Manufacturer Address : No. 5, East Section, Industrial Avenue, Xiaohan Town, Guanghan, Deyang City, Sichuan,...
Registrant Name : Korea Prime Pharmaceutical Co., Ltd.
Registration Date : 2022-08-29
Registration Number : No. 69-7-ND(4)
Manufacturer Name : Huatai Biopharm Inc.
Manufacturer Address : No. 5, East Section, Industrial Avenue, Xiaohan Town, Guanghan, Deyang City, Sichuan,...
Registrant Name : H-Linkers
Registration Date : 2021-07-29
Registration Number : No. 69-7-ND(3)
Manufacturer Name : Huatai Biopharm Inc.
Manufacturer Address : No. 5, East Section, Industrial Avenue, Xiaohan Town, Guanghan, Deyang City, Sichuan,...
Registrant Name : Iksoo Pharmaceutical Co., Ltd.
Registration Date : 2020-01-23
Registration Number : Su69-7-ND
Manufacturer Name : Huatai Biopharm Inc.
Manufacturer Address : No. 5, East Section, Industrial Avenue, Xiaohan Town, Guanghan, Deyang City, Sichuan,...
Registrant Name : Hanmi Pharmaceutical Co., Ltd.
Registration Date : 2024-05-28
Registration Number : No. 69-7-ND(6)
Manufacturer Name : Huatai Biopharm Inc.
Manufacturer Address : No. 5, East Section, Industrial Avenue, Xiaohan Town, Guanghan, Deyang City, Sichuan,...
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2021-04-09
Registration Number : No. 69-7-ND(1)
Manufacturer Name : Huatai Biopharm Inc.
Manufacturer Address : No. 5, East Section, Industrial Avenue, Xiaohan Town, Guanghan, Deyang City, Sichuan,...
Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.
Registration Date : 2021-04-09
Registration Number : No. 69-7-ND(2)
Manufacturer Name : Huatai Biopharm Inc.
Manufacturer Address : No. 5, East Section, Industrial Avenue, Xiaohan Town, Guanghan, Deyang City, Sichuan,...
Registrant Name : Geonil Pharmaceutical Co., Ltd.
Registration Date : 2021-03-25
Registration Number : No. 4692-4-ND(4)
Manufacturer Name : KD-Pharma Bexbach GmbH
Manufacturer Address : FabrikstraBe 51, D-66424 Homburg Germany (Am Kraftwerk 6, D-66450 Bexbach Germany)
Registrant Name : Korea Prime Pharmaceutical Co., Ltd.
Registration Date : 2019-11-29
Registration Number : 1881-1-ND
Manufacturer Name : KinOmegaBiopharm Inc.
Manufacturer Address : No.161, South Yinghuashan Road, Shifang, Deyang City, Sichuan, China
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
About the Company : We create chemistry for a sustainable future. In line with our corporate purpose, around 112,000 employees contribute to the success of our customers in nearly all sectors and alm...
About the Company : Guowei Pharmaceutical was established in 2005 and is headquartered in Chengdu High-tech Zone. Its subsidiaries include Chengdu Guowei Biopharmaceutical Co., Ltd., Sichuan Guowei Ph...
Details:
Woodward Pharma Services LLC, has acquired Lovaza (LO-VEY-ZA) soft gelatin capsules indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia from GlaxoSmithKline LLC (GSK).
Lead Product(s): Omega-3-Acid Ethyl Esters 90
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Lovaza
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Woodward Pharma Services
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition August 18, 2021
Lead Product(s) : Omega-3-Acid Ethyl Esters 90
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Woodward Pharma Services
Deal Size : Undisclosed
Deal Type : Acquisition
Woodward Pharma Services LLC Acquires LOVAZA(R) Capsules
Details : Woodward Pharma Services LLC, has acquired Lovaza (LO-VEY-ZA) soft gelatin capsules indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia from GlaxoSmithKline...
Brand Name : Lovaza
Molecule Type : Small molecule
Upfront Cash : Undisclosed
August 18, 2021
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14 Jul 2021
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