Generic Approved for Coreg CR
October 25, 2017 – The U.S. FDA has approved a generic, manufactured by Sun Pharmaceutical Industries, for Coreg CR® (carvedilol) extended release capsules, manufactured by GlaxoSmithKline. Carvedilol is an alpha/beta blocker indicated for the treatment of high blood pressure, heart failure, and other cardiovascular conditions. Recommended dosing of the extended release capsules is once per day, and there are four strengths available: 10mg, 20mg, 40mg, and 80mg.
Estimated U.S. sales for Coreg CR were $208 million, according to QuintilesIMS, in the twelve months ending August 31, 2017. Launch and pricing information for Sun’s generic are not yet available.
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.