10.01.2005 15:50:00
|
IVAX Receives Tentative Approval for Finasteride Tablets
Business Editors/Health/Medical Writers
MIAMI--(BUSINESS WIRE)--Jan. 10, 2005--IVAX Corporation (AMEX:IVX) (LSE:IVX.L) has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for finasteride tablets in 5mg dosage strength. Finasteride is the generic equivalent of Proscar(R), Merck & Co., Inc.'s drug for the treatment of benign prostatic hyperplasia (BPH). IVAX believes that it has first-to-file status on this drug and will be entitled to 180-days of marketing exclusivity upon receiving final approval. U.S. sales of finasteride tablets were $360 million for the twelve-month period ended September 2004.
IVAX continues its aggressive program to increase the number of products in its generic portfolio.
IVAX Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and internationally.
Copies of this and other news releases may be obtained free of charge from IVAX' website at http://www.ivax.com.
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 Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements, including the statements regarding IVAX' pending ANDAs and filing schedule for ANDA submissions, involve risks and uncertainties which may affect the company's business and prospects, including the risks that final approval of IVAX' ANDA for finasteride tablets in 5mg strength may be delayed or not received at all; that launch of the tablets may be delayed; that IVAX may not have first to file status; the impact of FDA's or other administrative or judicial agency's decisions on exclusivity periods; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; that IVAX may not receive approval of its pending ANDAs, or that if approved, the products will not be successfully commercialized; that IVAX may not file any additional ANDAs; and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Proscar(R) is a registered trademark of Merck & Co., Inc.
--30--JD/mi*
CONTACT: IVAX Corporation, Miami David Malina, 305-575-6043
KEYWORD: FLORIDA INDUSTRY KEYWORD: PHARMACEUTICAL PRODUCT SOURCE: IVAX Corporation
Copyright Business Wire 2005
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Nachrichten zu IVAX Corp.mehr Nachrichten
Keine Nachrichten verfügbar. |
Analysen zu IVAX Corp.mehr Analysen
Indizes in diesem Artikel
S&P 400 MidCap | 1 854,40 | -0,45% |