Generics to Vytorin Launched
April 26, 2017 – The U.S. FDA approved AB-rated generics to Vytorin® (ezetimibe and simvastatin), manufactured by Merck. Vytorin is used to lower high blood cholesterol, it is indicated for use as an adjunctive therapy to diet to treat patients with primary or mixed hyperlipidemia. It is also approved as an adjunct to other lipid-lowering treatments for patients with homozygous familial hypercholesterolemia (HoFH). Generic exclusivity was not granted. Shipments of the generics have already begun from at least three companies, Dr. Reddy’s Laboratories, Impax and Teva. According to IMS Health, Vytorin earned $687 million in sales for the twelve month period that ended on Feb. 28, 2017.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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.