Postmarket Requirements and Commitments

Center:	Both CBER and CDER CBER CDER
Applicant:
Product:
NDA/ANDA/BLA Number:
Requirement/Commitment Status:	Status Definitions
Required Under:	Accelerated Approval Animal Efficacy Rule Pediatric Research Equity Act FDAAA Section 505(o)(3)
NDA/ANDA/BLA Approval Date:	Date format: mm/dd/yyyy From: To:


	Downloadable Database File FDA Home \| Drugs Home \| Vaccines, Blood & Biologics Home PMC Coordinator: pmcweb@cder.fda.gov

7 of 880 Application(s)/Supplement(s)
You searched for:

Previous | Next

First | Last

Applicant	ABBOTT LABORATORIES
Product	KALETRA
NDA/BLA Number	21226
NDA/BLA Approval Date	09/15/2000
Annual Report Due Date (must be submitted within 60 days of this date)	09/15/2009
Annual Report Received	11/13/2008

Requirement/Commitment Number 3

Description	Analyze isolates from patients with virologic failure on Kaletra to determine associations between protease mutations and in vitro shifts in susceptibility to define the resistance profile of lopinavir. Projected Submission Date: Based on the availability of isolates, by the fourth quarter 2001; data would be provided by second quarter 2002.
Current Status	Submitted

Requirement/Commitment Number 7

Description	Evaluate the cross-resistance potential between Kaletra and amprenavir. Projected Submission Date: Based on the availability of isolates, by fourth quarter 2001; data would be completed by second quarter 2002.
Current Status	Released

Requirement/Commitment Number 15

Description	Evaluate pharmacokinetic/pharmacodynamic relationships in Studies M98-957 and M99-049. Projected Submission Date: Data for M98-957 by second quarter 2001; based on enrollment projection, 48 week data from M99-049 should be available third quarter 2002.
Current Status	Fulfilled

7 of 880 Application(s)/Supplement(s)
You searched for:

Previous | Next

First | Last