September 14, 2016 – The US FDA approved Yosprala™ (aspirin/omeprazole) delayed-release tablets, manufactured by Aralaz Pharmaceuticals, Inc. Yosprala is indicated for preventing cardiovascular events, (heart attacks) and cerebrovascular events (strokes), for adults who already have had an event and who are likely to get stomach ulcers if they take aspirin. Each tablet contains 40mg of immediate-release omeprazole, a proton pump inhibitor (PPI) that protects the stomach as well as either 81mg or 325mg of slow-release aspirin. Slow-release aspirin is enteric coated, meaning it does not dissolve in the stomach until after the omeprazole changes the levels of stomach acid, reducing the chances of ulcer-causing damage in the stomach. Yosprala should be swallowed whole once a day an hour or more before a meal. It does not substitute for immediate-release aspirin in emergency situations and it cannot be interchanged with separate omeprazole and aspirin tablets. Each prescription fill will include a medication guide for patients. Aralaz Pharmaceuticals, Inc. announced that Yosprala will be launched during the week of October 2, 2016.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.