Amneal Pharmaceuticals announced it has received final U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application for a generic version of Welchol (colesevelam HCI) tablets, 625 mg. Amneal has immediately initiated commercialization activities for this first-to-market opportunity.
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"We are pleased to be one of the first companies to receive approval and launch a generic version of Welchol," said Rob Stewart, President and Chief Executive Officer of Amneal. "The immediate launch of this product further enhances our generic portfolio and our commitment to provide patients with a more affordable treatment option."
Welchol had annual U.S. sales of approximately $526 million according to IQVIA for the 12 months ending February 2018.