FDA Approves Three Pliva Drugs, Lifts ANDA Hold
ePT--the Electronic Newsletter of Pharmaceutical Technology
Late last week, Pliva d.d. (Zagreb, Croatia) announced that the US Food and Drug Administration had granted final approval for its warfarin sodium tablets and azithromycin for oral suspension.
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.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
