IVAX Announces Generic Drug Approval for Albuterol Sulfate Inhalation Solution

Business Wire, Dec 21, 1999

Business Editors/Health & Medical Writers

MIAMI--(BUSINESS WIRE)--Dec. 21, 1999

IVAX Corporation (AMEX:IVX) today announced that the United States Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for albuterol sulfate inhalation solution, 0.083%, in 3 ml unit-dose vials. Albuterol sulfate is used to treat asthma and other respiratory diseases and is the generic equivalent of Schering-Plough Corporation's Proventil(R) inhalation solution. It has already been marketed in the U.K., Europe and Canada, and sales in the U.S. have begun recently through IVAX's Zenith Goldline Pharmaceuticals subsidiary. The product, for use in nebulizers, is manufactured at Steripak Limited of Runcorn, England, an IVAX subsidiary specializing in "blow-fill-seal" technology for sterile products.

"The FDA approval of our albuterol sulfate inhalation solution is an important step in enhancing our generic respiratory products franchise," said Dr. Rafick Henein, president and chief executive officer of Zenith Goldline Pharmaceuticals. "We expect this line to grow further with the anticipated FDA approval of two other generic inhalation solutions in early 2000. Our generic research and development program continues at a strong pace. In the first eleven months of the year we have received three final and five tentative approvals, with 24 ANDA's pending at the FDA."

IVAX Corporation, headquartered in Miami, Florida, is a holding company with subsidiaries engaged in the research, development, manufacture, and marketing of branded and generic pharmaceuticals and veterinary and diagnostic products in the U.S. and international markets.

Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties which may affect the company's business and prospects, and cause results to differ materially from those set forth in the forward-looking statements. These risks include, among other things, the risks that the company's generic albuterol sulfate inhalation solution may not obtain a significant share of the generic market for this product, and that this and other products for which tentative approvals have been granted may not be successfully commercialized. In addition to these factors, the economic, competitive, governmental, technological and other factors identified in IVAX's filings with the Securities and Exchange Commission could affect the forward-looking statements contained in this release.