FDA Approves Three Pliva Drugs, Lifts ANDA Hold

Late last week, Pliva d.d. (Zagreb, Croatia, www.pliva.com)announced that the US Food and Drug Administration had granted finalapproval for its warfarin sodium tablets and azithromycin for oralsuspension. Pliva also announced FDA's tentative approval for itsondansetron hydrochloride tablets. Azithromycin, warfarin, andondansetron hydrochloride are generic equivalents of Pfizer's"Zithromax," Bristol-Myers Squibb's "Coumadin," and GlaxoSmithKline's"Zofran," respectively.

The approvals follow FDA's favorable reception of Pliva's CorrectiveAction Plan, which was created to resolve problems cited in theagency's April 28 warning letter. Among the problems indicated in theletter were poor building maintenance and insufficient sanitization ofequipment at Pliva's production facilities in Zagreb. FDA said it wouldagain accept abbreviated new drug applications for productsmanufactured at the Zagreb facilities.