Colesevelam Hydrochloride Generic Gets FDA Approval


The 625 mg tablet Welchol was first approved for cholesterol and/or glycemic management by the FDA in 2000.

The US Food and Drug Administration has approved the Abbreviated New Drug Application (ANDA) for a generic version of colesevelam hydrochloride tablets (Welchol).

The therapy, a 625 mg lipid-lowering, is indicated to treat cholesterol levels, or improve glycemic control in patients with type 2 diabetes. It is commonly used as part of a treatment regimen with other cholesterol-lowering drugs.

The new drug application (NDA) for colesevelam hydrochloride, marketed in the US by company Daiichi Sankyo, was first approved in 2000.

Amneal Pharmaceuticals, a Bridgewater, NJ-based manufacturer of generic, brand, and biosimilar products, shared intentions to immediately begin commercialization activities in response to this first-to-market indication.

Rob Stewart, president and chief executive officer of Amneal, said in a statement the company is pleased to be among the first companies able to provide a generic version of Welchol.

“The immediate launch of this product further enhances our generic portfolio and our commitment to provide patients with a more affordable treatment option,” Stewart said.

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