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Zagreb, 23 December 2005
PLIVA d.d. ("PLIVA") announced today that the U.S. Food and Drug Administration ("FDA") has granted tentative approval for its Abbreviated New Drug Application ("ANDA") for Sertraline Hydrochloride tablets, 25 mg (base), 50 mg (base) and 100 mg (base).
Sertraline Hydrochloride is the AB-rated generic equivalent of Pfizer Inc.'s Zoloft, indicated for the treatment of depression and anxiety, with annual sales of over USD 3 billion.
More information about PLIVA can be found at www.pliva.com
For additional information, please contact:
Marija Mandic
Executive Director
Investor Relations & Corporate Communications
Tel: +385 1 6160 355, 6120 909
Fax: +385 1 6114 413
E-mail: Marija.Mandic@pliva.com
This release contains certain "forward-looking statements", relating to the Group's business, which can be identified by the use of forward-looking terminology such as "will", "planned", "expectations", "forecast" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of new products expected to be introduced or have been introduced by the Group companies and anticipated customer demand for such products. Such statements reflect the current views of the Group with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the Group to be materially different from any future results that may be expressed or implied by such forward-looking statements. |
