Welchol Tablets Generic Launched
May 17, 2018 – The U.S. FDA has approved Amneal Pharmaceuticals’ AB-rated generic for Daiichi-Sankyo’s Welchol® (colesevelam) 625mg tablets. Amneal launched the generic immediately upon approval.
Colesevelam is indicated, in conjunction with diet and exercise, to treat high cholesterol in adults who have primary hyperlipidemia. It can be used as either a monotherapy or with a statin. The drug is also indicated as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes. Recommended dosing is the same for both indications: either 6 tablets once daily, or 3 tablets twice daily, taken with food and drink.
The FDA first approved colesevelam in 2000. Brand name Welchol is also available in a powdered form for oral suspension, which does not yet have an FDA-approved generic. The oral solution can be used by adults who have difficulty swallowing. It is also indicated for use in conjunction with diet and exercise as either a monotherapy or with a statin to treat high cholesterol in pediatric patients 10 to 17 years of age who have heterozygous familial hypercholesterolemia and have failed an adequate trial of diet therapy.
According to IQVIA, U.S. sales for brand name Welchol reached $526 million in the 12 months ending in February 2018.
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.