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Zdrowie i gospodarka · 9.04.2007

Trimethobenzamide Hydrochloride Suppositories; Withdrawal of Approval

The Food and Drug Administration (FDA) is announcing the resolution of issues concerning trimethobenzamide hydrochloride suppositories. This notice announces the withdrawal of approval of the new drug application (NDA) for Tigan (trimethobenzamide hydrochloride) Suppositories. The notice also declares that the marketing of unapproved trimethobenzamide hydrochloride suppository products is unlawful and subject to FDA regulatory action. FDA is taking these actions because trimethobenzamide hydrochloride suppositories lack substantial evidence of effectiveness.

Source: Federal Register — Food and Drug AdministrationOpen original release →