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news.The FDA has approved two generic drugs made by Croatian generic drugmaker Pliva and given tentative approval to a third. The FDA decision signifies that the agency is satisfied with the measures the company has taken to correct problems at its manufacturing facilities in Zagreb.
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The FDA granted final approval for the company’s azithromycin for oral suspension, a generic version of Pfizer’s antibiotic Zithromax, and warfarin sodium tablets, a generic version of Bristol-Myers Squibb’s anticoagulant Coumadin.
The agency further granted tentative approval for Pliva’s ondansetron hydrochloride tablets, its generic version of GlaxoSmithKline’s Zofran, which is used to treat chemotherapy-induced nausea and vomiting.
Pliva announced in May that it had received an FDA warning letter pertaining to certain of its production facilities in Zagreb. At that time, the FDA placed a hold on all approvals for drugs manufactured at these facilities. However, a “corrective action plan” undertaken by the company has now persuaded the agency to lift this embargo.
Pliva is currently the subject of a $2.3 billion bidding war between US-based Barr and Iceland-based Activas. The takeover bids are part of a general trend of consolidation in the generics industry with both Barr and Activas seeking to scoop up Pliva in order to become the world’s third largest producer of generic pharmaceutical products.