Forest Laboratories Announces Acceptance of The NDA Filing for Acamprosate for the Treatment of Alcohol Dependence
Product Is Granted Expedited FDA Review
Public Company Information:
Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, announced today that the NDA for Acamprosate had been filed by its licensor, Lipha S.A., a pharmaceutical subsidiary of Merck KGaA, Darmstadt, Germany, and has been accepted by the FDA and will be granted for expedited review.
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 and we look forward to marketing it in the United States."
Except for the historical information contained herein, this release contains forward looking statements that involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products and the risk factors listed from time to time in the Company's SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2001 and the quarterly report on Form 10-Q for the periods ended June 30, 2001, September 30, 2001 and December 31, 2001, along with any Merck KGaA reports.