Andrx Announces FDA Approvable Letter On Additional Indication For Altocor.

Business Editors & Health/Medical Writers

Andrx Corporation (Nasdaq:ADRX) today announced that the United States Food and Drug Administration (FDA) has issued an approvable letter for an additional indication for the use of Altocor(TM), Andrx's lipid lowering drug which FDA recently approved for marketing. The additional indication covers the use of Altocor for the primary prevention of coronary heart disease in patients who have average to moderately elevated total cholesterol and LDL-cholesterol and below average HDL-cholesterol. Following expiration of the exclusivity rights of others in September 2002, Andrx expects to receive approval for this new indication which Andrx believes will significantly expand Altocor's potential patient population. Andrx has already begun shipping its Altocor product nationwide and its sales representatives will begin detailing physicians later this month.

Commenting on this development, Richard J. Lane, Andrx Chief Executive Officer, said: "Altocor's new indication will be a significant opportunity for Andrx for several reasons. First, there is only one other lipid-lowering agent with this type of indication. Second, given the National Cholesterol Education Panel's statement that 36 million Americans are candidates for cholesterol-lowering therapy, including an increased number of primary prevention patients, this indication will expand Altocor's potential patient population. Finally, many patients will be able to benefit from the impressive efficacy and favorable economic value Altocor represents. Its efficacy, especially at a starting dose of 60 mg, which achieved a 41% reduction in LDL-cholesterol, combined with its favorable pricing offers consumers highly cost-effective therapy. When this new indication is approved, we will also be able to promote Altocor's cardioprotective benefits as well as its importance in treating cardiovascular disease."

This new indication resulted from the AFCAPS/TexCAPS study that investigated prevention of heart attacks in people devoid of heart disease. Evan Stein, MD, Ph.D., a co-author of that study commented: "The AFCAPS/TexCAPS indication is important since this primary prevention indication covers the majority of patients eligible for treatment with statin drugs. This additional indication for Altocor will provide physicians with an excellent addition to their lipid management choices."

Altocor is a once-daily HMG-CoA reductase inhibitor product, currently indicated as an adjunct to diet for the reduction of elevated total-cholesterol, LDL-cholesterol, Apolipoprotein B, triglycerides, and to increase HDL-cholesterol in patients with primary hyper-cholesterolemia. Altocor is also indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total cholesterol and LDL-cholesterol to target levels.

Since lovastatin has a relatively short half-life in the body, Altocor utilizes Andrx's patented and proprietary SCOT(TM) technology to achieve sustained blood levels of the active drug, resulting in LDL-cholesterol lowering of 24% to 41% for the 10 mg to 60 mg dosing ranges approved. Lovastatin has a long history of safe use in over 24 million patient-years of exposure. The United States market for lipid lowering drugs in which Altocor competes currently exceeds $12 billion per year and is expected to continue to grow.

In clinical studies with Altocor, adverse reactions have generally been mild and transient. Pooled results from clinical studies with Altocor show that the most frequently reported adverse reactions in the Altocor group were infection, headache and accidental injury. Similar incidences of these adverse reactions were seen in the Altocor and placebo groups. The most frequent adverse events thought to be related to Altocor were nausea, abdominal pain, insomnia, dyspepsia, headache, asthenia, and myalgia. In rare cases, inhibitors of HMG CoA reductase, like Altocor, can cause liver dysfunction and myopathy. These effects and other safety and efficacy information are summarized in the Altocor Package Insert. The full prescribing information is available on Andrx's website at http://www.andrx.com.

Andrx Corporation is a specialty pharmaceutical company engaged in the formulation and commercialization of oral controlled-release generic and brand pharmaceuticals utilizing its proprietary drug delivery technologies.

Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained in this report that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, no assurance can be given as to when Altocor will be awarded this new indication or whether that indication will significantly affect the commercial success of Altocor, and words such as "may," "will," "to," "expect," "plan," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative or other variations thereof or comparable terminology is intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties, including those risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission.

This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com