Generic Xenazine Launched
September 8, 2015 – The U.S. Food and Drug Administration approved Durlaza (162.5mg extended release aspirin) for the secondary prevention of stroke and acute cardiac events such as myocardial infarction in high-risk patients. Durlaza is manufactured by New Haven Pharmaceuticals.
Due to its ability to inhibit platelet aggregation, low-dose aspirin has been proven to reduce the risk of secondary cardiovascular events and mortality in high-risk patients with stable cardiovascular disease. This formulation allows for prolonged absorption and sustained platelet exposure to aspirin. Similarly to immediate-release aspirin, side effects include an increased risk of bleeding and gastric ulceration. Durlaza may cause fetal harm when administered in pregnant women. Durlaza will be available by prescription only in the last quarter of 2015.
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 a 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. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.