FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Jan. 14, 2004--Andrx Corporation ("Andrx" or "Company") (Nasdaq:ADRX) today announced that the United States Food and Drug Administration (FDA) has issued an approvable letter for the Company's new drug application ("NDA"), pursuant to Section 505(b)(2) of the Federal Food Drug and Cosmetic Act, for valproate delayed release tablets (125 mg, 250 mg and 500 mg). An approvable letter sets out the conditions that a company must meet in order to obtain FDA final marketing approval. Though Andrx intends to address the requirements of the approvable letter in the near future, the approval and commercial sale of this product are likely to be further delayed as a result of the patent infringement litigation pending against the Company by Abbott Laboratories.
Andrx is seeking approval to market this product for the treatment of manic episodes associated with bipolar disorder, various seizure disorders and prophylaxis of migraine headaches. Andrx's product will compete in the same market as the Depakote(R) family of brand products that had total U.S. sales in 2002 of approximately $1 billion.
Source: Andrx Corporation