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PLIVA Announces FDA Approvals for Azithromycin Oral Suspension, Warfarin and Ondansetron Hydrochloride |
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07 Jul 2006 |
Announced today that the U.S. Food and Drug Administration (“FDA”) has granted final approval for its Abbreviated New Drug Applications (“ANDAs”) for Azithromycin for Oral Suspension and Warfarin Sodium Tablets and has granted a tentative approval for its ANDA for Ondansetron Hydrochloride Tablets.
ZAGREB, Croatia | Jul 07, 2006 | PLIVA d.d. (LSE: PLVD) announced today that the U.S. Food and Drug Administration (“FDA”) has granted final approval for its Abbreviated New Drug Applications (“ANDAs”) for Azithromycin for Oral Suspension and Warfarin Sodium Tablets and has granted a tentative approval for its ANDA for Ondansetron Hydrochloride Tablets.
These approvals reflect the FDA's positive reaction to PLIVA's Corrective Action Plan and the steps already taken by PLIVA to implement it. The plan was developed to address the issues raised in the Warning Letter announced on 08 May 2006 with respect to certain PLIVA production facilities in Zagreb. The FDA has now lifted the hold it previously imposed on approval of ANDAs for products from these facilities.
Azithromycin for Oral Suspension USP, 100mg/5 mL and 200 mg/5 mL are AB-rated generic equivalents of Pfizer’s Zithromax® for Oral Suspension. Warfarin Sodium Tablets USP, 1mg, 2mg, 2.5mg, 3mg, 4mg, 5mg, 6mg, 7.5mg and 10mg, are the AB-rated generic equivalents of Bristol Myers Squibb's Coumadin®. Ondansetron Hydrochloride Tablets, 4mg, 8mg and 24mg are the AB-rated generic equivalents of GlaxoSmithKline's Zofran®.
PLIVA will launch Azithromycin for Oral Suspension this week and will launch Warfarin tablets at a later date. Ondansetron Hydrochloride is a Paragraph III/IV filing and approval for the first to file applicant is expected in late December 2006, with our approval expected in June 2007 following expiration of the exclusivity period.
These products will be manufactured at and sourced from PLIVA’s manufacturing facilities in Zagreb.
More information about PLIVA can be found at www.pliva.com.
For additional information, please contact:
Marija Mandić
Executive Director
Investor Relations & Corporate Communications
Tel: +385 1 6160 355
E-mail:
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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.
SOURCE: PLIVA d.d. |
