Application Nr Approved Date Route Status External Links
NDA205103 2016-09-14 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Yosprala, A Combination Of Aspirin And Omeprazole, Is Indicated For Patients Who Require Aspirin For Secondary Prevention Of Cardiovascular And Cerebrovascular Events And Who Are At Risk Of Developing Aspirin Associated Gastric Ulcers. The Aspirin Component Of Yosprala Is Indicated For: Reducing The Combined Risk Of Death And Nonfatal Stroke In Patients Who Have Had Ischemic Stroke Or Transient Ischemia Of The Brain Due To Fibrin Platelet Emboli, Reducing The Combined Risk Of Death And Nonfatal Mi In Patients With A Previous Mi Or Unstable Angina Pectoris, Reducing The Combined Risk Of Mi And Sudden Death In Patients With Chronic Stable Angina Pectoris, Use In Patients Who Have Undergone Revascularization Procedures (coronary Artery Bypass Graft [cabg] Or Percutaneous Transluminal Coronary Angioplasty [ptca]) When There Is A Pre-Existing Condition For Which Aspirin Is Already Indicated. The Omeprazole Component Of Yosprala Is Indicated For Decreasing The Risk Of Developing Aspirin-Associated Gastric Ulcers In Patients At Risk For Developing Aspirin-Associated Gastric Ulcers Due To Age (≥ 55) Or Documented History Of Gastric Ulcers. Limitations Of Use : Yosprala Contains A Delayed-Release Formulation Of Aspirin And It Is Not For Use As The Initial Dose Of Aspirin Therapy During Onset Of Acute Coronary Syndrome, Acute Myocardial Infarction Or Before Percutaneous Coronary Intervention (pci), For Which Immediate-Release Aspirin Therapy Is Appropriate. Yosprala Has Not Been Shown To Reduce The Risk Of Gastrointestinal Bleeding Due To Aspirin. Do Not Substitute Yosprala With The Single-Ingredient Products Of Aspirin And Omeprazole. Yosprala Is A Combination Of Aspirin, An Anti-Platelet Agent, And Omeprazole, A Proton Pump Inhibitor (ppi), Indicated For Patients Who Require Aspirin For Secondary Prevention Of Cardiovascular And Cerebrovascular Events And Who Are At Risk Of Developing Aspirin Associated Gastric Ulcers. The Aspirin Component Of Yosprala Is Indicated For: Reducing The Combined Risk Of Death And Nonfatal Stroke In Patients Who Have Had Ischemic Stroke Or Transient Ischemia Of The Brain Due To Fibrin Platelet Emboli, Reducing The Combined Risk Of Death And Nonfatal Mi In Patients With A Previous Mi Or Unstable Angina Pectoris, Reducing The Combined Risk Of Mi And Sudden Death In Patients With Chronic Stable Angina Pectoris, Use In Patients Who Have Undergone Revascularization Procedures (coronary Artery Bypass Graft [cabg] Or Percutaneous Transluminal Coronary Angioplasty [ptca]) When There Is A Pre-Existing Condition For Which Aspirin Is Already Indicated. The Omeprazole Component Of Yosprala Is Indicated For Decreasing The Risk Of Developing Aspirin Associated Gastric Ulcers In Patients At Risk For Developing Aspirin-Associated Gastric Ulcers Due To Age (≥ 55) Or Documented History Of Gastric Ulcers. (1) Limitations Of Use: Not For Use As The Initial Dose Of Aspirin Therapy During Onset Of Acute Coronary Syndrome, Acute Myocardial Infarction Or Before Percutaneous Coronary Intervention. (1) Has Not Been Shown To Reduce The Risk Of Gastrointestinal Bleeding Due To Aspirin. (1) Do Not Substitute Yosprala With The Single-Ingredient Products Of Aspirin And Omeprazole. (1)

All Formulated Excipients (15 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Starch, Corn STARCH, CORN Unresolved
3. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
8. Povidones POVIDONES Unresolved
9. Sodium Phosphate, Dibasic, Anhydrous SODIUM PHOSPHATE, DIBASIC, ANHYDROUS Molecular
10. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
11. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
12. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
13. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
14. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
15. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Aspirin ASPIRIN ZINC53
2. Omeprazole OMEPRAZOLE ZINC4693575

Comments