Argentina - Drug Information Association

submitted by SmithKline Beecham Corp. doing business as (d/b/a) GlaxoSmithKline, indicated for the treatment of patients
with varieties of non-Hodgkin’s lymphoma known as CD20 antigen-expressing relapsed or refractory, low grade, follicular,
or transformed non-Hodgkin’s lymphoma, who have not received the drug Rituximab; (3) NDA 21–673, tradename CLOLAR
(clofarabine) for intravenous infusion, application submitted by Genzyme Corp., indicated for the treatment of pediatric
patients 1 to 21 years old with acute lymphoblastic leukemia (ALL) whose disease has not responded to or has relapsed
following treatment with at least two prior chemotherapy regimens; (4) NDA 21–877, tradename ARRANON (nelarabine)
Injection, application submitted by GlaxoSmithKline, indicated for the treatment of patients with types of leukemia or
lymphoma known as T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not
responded to or has relapsed following treatment with at least two chemotherapy regimens; (5) BLA 125147, tradename
VECTIBIX (panitumumab), application submitted by Amgen Inc., indicated for the treatment of EGFR-expressing, metastatic
colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing
chemotherapy regimens; and (6) sNDA 21–588/025, tradename GLEEVEC (imatinib mesylate) tablets, application submitted
by Novartis Pharmaceuticals Corp., indicated for the adjuvant (additional) treatment of adult patients following complete
gross resection (removal) of a form of cancer known as Kit (CD117) positive gastrointestinal stromal tumors (GIST). Based
on the updates provided, the committee will have a general discussion centering on possible ways to improve the planning
and conduct of trials to confirm clinical ...
Document date: 08-Feb-2011
Type of text: Briefing Information
Regulatory version: None
Language: English
USA - Drug Safety Communication: AVANDIA (rosiglitazone) Labels Now Contain
Updated Information about Cardiovascular Risks & Use in Certain Patients, 03-
Feb-2011
In response to data highlighting an elevated risk of heart attacks in patients treated with rosiglitazone, the FDA announced
on September 2010 that the use of rosiglitazone-containing medicines would be restricted to patients with Type 2 diabetes
who cannot control their blood sugar on other medicines. This Drug Safety Communication informs that the labeling and the
Medication Guide for AVANDIA (rosiglitazone) have been updated to warn about these potential cardiovascular risks. The
agency is also working on a REMS program which should be approved by Spring 2011.
Comment: This document is divided into four sections: Safety Announcement, Additional Information for Patients,
Additional Information for Healthcare Professionals and Data Summary. At the end of this document, we provide you with a
list of previous safety communications available in IDRAC.
Document date: 03-Feb-2011
Type of text: Communication
Regulatory version: None
Language: English
USA - ANIP Aquisition Company, 11-19-Jun-2009: FDA 483
This form FDA 483 was issued at the conclusion of an inspection of ANIP Acquisition Company (Windsoir Mill, Maryland)
which revealed deviations of the Adverse Drug Experience reporting system. Five deviations are reviewed in this document.
N.B.: This document has been prepared by IDRAC by integrating FDA documents acquired under the Freedom of
Information Act, into one comprehensive document.
Document date: 19-Jun-2009
Type of text: EIR
Regulatory version: None
Language: English
USA - Ben Venue Laboratories Inc., 28-Feb-24-May-2002: EIR, FDA 483
This was a GMP inspection of a small volume parenteral manufacturer. Certain deviations include employee actions in the
aseptic areas, physical status of the aseptic areas, media fills. The Form FDA 483 is attached to this document. 14
deviations are reviewed in this document. N.B.: This document has been prepared by IDRAC by integrating FDA documents
acquired under the Freedom of Information Act, into one comprehensive document.
Document date: 24-May-2002
Type of text: EIR
Regulatory version: None
Language: English
USA - Bryant Ranch Prepack, 02-11-Jun-2009: FDA 483
This form FDA 483 was issued at the conclusion of an inspection of Bryant Ranch Prepack (Hollywood, California) which
revealed significant deviations for Current Good Manufacturing Practice. Six deviations are reviewed in this document. N.B.:
This document has been prepared by IDRAC by integrating FDA documents acquired under the Freedom of Information Act,
into one comprehensive document.
Document date: 11-Jun-2009