FDA approves Glenmark’s Welchol generic

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FDA approves Glenmark’s Welchol generic

By David Salazar - 05/22/2018
The Food and Drug Administration on Monday approved Glenmark Pharmaceuticals’ Welchol generic (colesevelam tablets).

The drug is indicated as an adjunct to diet and exercise to reduce elevated LDL cholesterol in patients with primary hyperlipidemia. It also is indicated as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes.

Glenmark said that it had already started supplying the product in the United States. The company’s Welchol generic is available in 625-mg dosage strength. The drug had a U.S. market size of roughly $519.9 million for the 12 months ended March 2018, according to IQVIA data.

Glenmark currently has a portfolio of 135 products it’s authorized to distribute in the United States, as well as 62 pending abbreviated new drug applications before the FDA.

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