FDA rejects Merck's NDA submission for acamprosate

Published: 22-Aug-2002
Regulatory


The US FDA has rejected the New Drug Application (NDA) submitted by Merck Sante, a French subsidiary of Merck KGaA in Germany, for acamprosate, a medication designed to help maintain abstinence in patients with alcohol dependence.

Merck KGaA's NDA for acamprosate was filed with the FDA in December and received a priority review designation. But the FDA has indicated that the data submitted did not adequately establish the safety and efficacy of acamprosate and has requested at least one additional US clinical trial, as well as additional pharmacokinetic analyses and additional preclinical studies.

Acamprosate is currently approved and available in 24 countries outside the US and was approved in the UK in 1995 and in Australia and Italy in 1999. In Europe, it is marketed under the brand name Campral.

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