PLIVA Announces Approval for Azithromycin Tablets
PLIVA d.d. (“PLIVA”) announced today that the U.S. Food and Drug Administration (“FDA”) has granted final approval for its Abbreviated New Drug Application (“ANDA”) for Azithromycin Tablets, 250 mg, 500 mg and 600 mg.
Azithromycin is the AB-rated generic equivalent of Pfizer Inc.’s Zithromax, an antibiotic indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of bacteria. It is most often used to treat respiratory infections. Azithromycin can also be used to treat skin infections and some sexually transmitted diseases in adults.
The brand product, Zithromax tablets, has annual sales of over USD 1.6 billion.
More information about PLIVA can be found at www.pliva.com.
For additional information, please contact:
Executive Director Investor Relations
& Corporate Communications
Tel: +385 1 6160 355, 6120 909
Fax: +385 1 6114 413
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.
- 2005-11-15 PR Azithromycin US Approval.pdf ( 62,2 KB)