Merck KGaA Announces Acceptance of NDA Filing for Acamprosate

Treatment for Alcohol Dependence Is Granted Expedited FDA Review

28-Feb-2002

February 27, 2002 Darmstadt, Germany - Merck KGaA announced today that its New Drug Application (NDA) for acomprosate has been accepted by the U.S. food and Drug Administration and will be granted expedited review. Forest Laboratories Inc. of New York is Merck KGaA's partner for marketing and distribution of acamprosate in the U.S. Howard Solomon, Chairman and Chief Executive Officer of Forest, stated: "While of course acceptance for filing of an NDA by the FDA does not assure approval, we believe the studies included in the NDA and the experience with acamprosate in the markets where it has been approved for years, indicate that it is a well-tolerated and useful drug in the treatment of alcoholism. We look forward to marketing it in the United States." A drug for the treatment of alcohol addiction, acamprosate has been approved in most major European markets as well as in Latin America and Australia. It is marketed there under the brand name Campral.

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