Pliva gets FDA OK for Azithromycin, Warfarin, Ondansetron hydrochloride

By Elaine Rigoli

Tampa, Fla., July 7 - The Food and Drug Administration has lifted its hold and has granted final approval for Pliva dd's abbreviated New Drug Applications for Azithromycin for oral suspension and Warfarin sodium tablets and has granted a tentative approval for its abbreviated NDA for Ondansetron hydrochloride tablets.

The company said these approvals reflect the FDA's positive reaction to its corrective action plan and the steps already taken to implement it. The plan was developed to address the issues raised in the warning letter announced May 8 with respect to certain Pliva production facilities in Zagreb, Croatia.

Azithromycin is the generic equivalent of Pfizer's Zithromax; Warfarin is the generic equivalent of Bristol Myers Squibb's Coumadin; and Ondansetron is the generic equivalent of GlaxoSmithKline's Zofran.

Pliva said it will launch Azithromycin for oral suspension this week and will launch Warfarin tablets at a later date.

Ondansetron hydrochloride is a paragraph 3/ 4 filing and approval for the first to file applicant is expected in late December, with approval expected in June 2007 following expiration of the exclusivity period.

Pliva is a pharmaceutical company located in Zagreb, Croatia.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.