Argentina - Drug Information Association

numbers.
Comment: Updated: - The Open Public Hearing at FDA Advisory Committee Meetings (54167)
Document date: 03-Feb-2011
Type of text: Explanatory
Language: English
USA - List of New Molecular Entities (NMEs), 2011
This document contains the list of NMEs approved in calendar year 2011 with all relevant details - NDA Number, Approval
Date, Generic and Trade Names, Dosage form, Applicant's Name, Classification, and Indications for which they have been
approved.
Comment: This document has been revised to include the REMS of VIIBRYD.
Document date: 03-Feb-2011
Type of text: Explanatory
Language: English
USA - US Reference Texts: Vaccines & Related Biological Products Advisory
Committee (VRBPAC) - 2011 Meetings
This document contains all relevant information related to the 2011 meetings of the Vaccines and Related Biological
Products Advisory Committee.
Document date: 21-Jan-2010
Type of text: Explanatory
Language: English
USA - Guidance Bulletin: The Open Public Hearing at FDA Advisory Committee
Meetings, Updated 03-Feb-2011
This guidance bulletin summarizes the content and regulatory history of the FDA Guidance for the public, FDA Advisory
Committee Members, and FDA Staff:: "The Open Public Hearing at FDA Advisory Committee Meetings" and provides links to
public dockets/comments and IDRAC search information related to the topic of the guidance.
Comment: Following the release of a final version to this FDA guidance, the guidance bulletin has been revised to include a
comparison to the previously released draft version.
Document date: 03-Feb-2011
Type of text: Guidance Bulletin
Language: English
USA - Product Approval Bulletin: Egrifta (tesamorelin) injection, NDA 22-505,
Theratechnologies, Inc., 10-Nov-2010
This product approval bulletin summarizes the regulatory history of Egrifta (tesamorelin) injection, approved by the FDA to
reduce excess abdominal fat (visceral adipose tissue [VAT]) in HIV-infected patients with lipodystrophy.
Document date: 10-Nov-2010
Type of text: Product Approval Bulletin
Language: English
USA - Oncologic Drugs Advisory Committee (Draft Agenda and Questions):
Updates on the Status of Phase 4 Clinical Studies for NDAs and BLAs Approved
Under 21 CFR 314.500 and 601.40 Prior to January 1, 2009 for: ERBITUX
(cetuximab), BEXXAR (tositumomab/iodine I 131 tositumomab), CLOLAR
(clofarabine), ARRANON (nelarabine), VECTIBIX (panitumumab) & GLEEVEC
(imatinib mesylate), 08-Feb-2011
On February 08, 2011, the Oncologic Drugs Advisory Committee members will hear updates on new drug applications
(NDAs) and biologics license applications (BLAs) approved under 21 CFR 314.500 and 601.40 (subpart H and subpart E,
respectively, accelerated approval regulations) prior to January 1, 2009. These updates will provide information related to
the status of phase IV clinical studies and to difficulties associated with completion of phase IV commitments. Phase IV
studies are postmarketing studies to confirm clinical benefit of a drug after it receives accelerated approval. Specifically, the
committee will receive updates on the following products: (1) BLA 125084, trade name ERBITUX (cetuximab), application
submitted by Imclone Systems Inc., used in combination with the anticancer agent irinotecan and indicated for the
treatment of epidermal growth factor receptor (EGFR)-expressing colorectal cancer that has metastasized (spread beyond
the colon or rectum) in patients for whom chemotherapy using irinotecan alone is ineffective or less effective; (2)
supplemental BLA (sBLA) 125011/24, trade name BEXXAR (tositumomab and Iodine I 131 tositumomab), application
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,