Pharmaceutical company Amneal Pharmaceuticals Inc (NYSE:AMRX) disclosed on Thursday the receipt of final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for the generic version of Welchol (colesevelam HCI) tablets in 625 mg.
Effective immediately, the company has launched the commercialisation activities for this first-to-market generic Welchol (colesevelam HCI) tablets, 625 mg.
For the 12 months ending February 2018, Welchol had annual US sales of about USD526m according to IQVIA.
WELCHOL (colesevelam hydrochloride) is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent intended for oral administration,concluded the company.
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