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Drug Information Resources

IDIS Logo   IDIS Monthly Update Information - November 2012

NEW DRUG TERM
AGS-PSCA
AM-211
APR-246
AZD-9056
BL-1020
CEFCAPENE
DESMETHOXYFALLYPRIDE, F18-
EFATUTAZONE
ELDECALCITOL
FSPG, F18-
GS-9451
GSK-679586
IR-3535
LEMON EUCALYPTUS
LFF-571
NOROVIRUS, GII4
OMADACYCLINE
RIX-FP
SECUKINUMAB
TD-1792
VP-20621

CODE
10120301
92000386
10121043
95000353
28160888
8120677
36680131
10121044
88160011
36680130
8180124
82000571
94040833
92510289
8122956
80080012
8122955
20121625
82000570
8122954
56080079


NEW DISEASE TERM
TRANSPLANT, OVARY

CODE
65.92



DRUG NAME/CODE CHANGES

OLD TERM & CODE
BMS-201038 24060028
DMAG, 17- 10030066
PF-299804 10120963
RG-7128 8180890
YH-1885 56260609

NEW TERM & CODE
LOMITAPIDE 24060028
ALVESPIMYCIN 10030066
DACOMITINIB 10120963
MERICITABINE 8180890
REVAPRAVAN 56260609


FDA APPROVAL PACKAGES

Article Numbers 686179-686192: Linaclotide, Linzess Capsules, FDA Approval Package for NDA 202811. FDA Approval Package 2012.

Article Numbers 686164-686178: Regorafenib, Stivarga Tablets, FDA Approval Package for NDA 203085. FDA Approval Package 2012.

Article Numbers 686148-686163: Cobicistat-Elvitegravir-Emtricitabine-Tenofovir Disoproxil Fumarate, Stribild, FDA Approval Package for NDA 203100. FDA Approval Package 2012.


ADVISORY COMMITTEE MEETINGS

Article Numbers 686200-686206: Gastrointestinal Drugs Advisory Committee Meeting, October 16, 2012. FDA Advisory Committee 2012.

Article Numbers 686193-686199: Endocrinologic and Metabolic Drugs Advisory Committee Meeting, October 18, 2012. FDA Advisory Committee 2012.

Article Numbers 685380-685385: Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting, August 9, 2012. FDA Advisory Committee 2012.

Article Numbers 685374-685379: Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting, August 8, 2012. FDA Advisory Committee 2012.

Article Numbers 685364-685373: Cardiovascular and Renal Drugs Advisory Committee Meeting, September 13, 2012. FDA Advisory Committee 2012.


CONTINUING EDUCATION ARTICLES

Article Number 686319: Anonymous. Choice of an Oral Anticoagulant in Atrial Fibrillation (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 686318-686319]. Med Lett Drugs Ther 2012, 54:79-80.

Article Number 686318: Anonymous. Influenza Vaccine for 2012-2013 (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 686318 and 686319]. Med Lett Drugs Ther 2012, 54:77-78.

Article Number 686316: Anonymous. Insect Repellents (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for These Articles in this Issue, Article Numbers 686314-686316]. Med Lett Drugs Ther 2012, 54:75-76.

Article Number 686315: Anonymous. Endocarditis Prophylaxis for Dental Procedures (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for These Articles in this Issue, Article Numbers 686314-686316]. Med Lett Drugs Ther 2012, 54:74-75.

Article Number 686314: Anonymous. Prevention and Treatment of Pertussis (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for These Articles in this Issue, Article Numbers 686314-686316]. Med Lett Drugs Ther 2012, 54:73-74.

Article Number 686313: Anonymous. Citalopram (Celexa) and QT Interval Prolongation (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 686312 and 686313]. Med Lett Drugs Ther 2012, 54:71-72.

Article Number 685997: Cada D J, Demaris K, Levien T L, Baker D E. Lucinactant (0.15 CEU). Hosp Pharm 2012, 47:788-793.

Article Number 684981: Anonymous. Antimicrobial Prophylaxis for Surgery (0.2 CEU). Treat Guidel Med Lett 2012, 10:73-78.


BLACK BOX WARNINGS

Article Number 686330: Revised (7/9/2012): Oxymorphone (Extended Release): FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 615541]. 2012.

Article Number 686329: Revised (7/9/2012): Oxycodone (Extended Release): FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 560809]. 2012.

Article Number 686328: Revised (7/9/2012): Morphine (Extended Release): FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 555334]. 2012.

Article Number 686327: Revised (7/9/2012): Methadone (Extended Release): FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 571390]. 2012.

Article Number 686326: Revised (8/24/2012): Hydromorphone: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 561303]. 2012.

Article Number 686325: Revised (7/9/2012): Fentanyl (Transdermal): FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 599806]. 2012.

Article Number 686324: Revised (9/14/2012): Deferasirox: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 633852]. 2012.

Article Number 686323: Revised (7/17/2012): Dantrolene: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 557159]. 2012.

Article Number 686322: Revised (8/14/2012): Bupropion: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 622360]. 2012.

Article Number 686321: Revised (7/9/2012): Buprenorphine (Transdermal): FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 650564]. 2012.

Article Number 686320: Emtricitabine & Tenofovir Disoproxil Fumarate: FDA Black Box Warning. 2012.


PRIORITY CLINICAL PRACTICE GUIDELINES

Article Number 686209: Anonymous. Full Guideline. Psoriasis: The Assessment and Management of Psoriasis. NICE Clinical Guideline No. 153 (Ref Art 686210). NICE Clin Guidel 2012.

Article Number 686207: Anonymous. Full Guideline. Crohn's Disease: Management in Adults, Children and Young People. NICE Clinical Guideline No. 152 (Ref Art 686208). NICE Clin Guidel 2012.

Article Number 686103: Bertsias G K, Tektonidou M, Amoura Z, Aringer M, et al. Joint European League Against Rheumatism and European Renal Association-European Dialysis and Transplant Association (Eular/Era-Edta) Recommendations for the Management of Adult and Paediatric Lupus Nephritis. Ann Rheum Dis 2012, 71:1771-1782.

Article Number 685836: Steg P G, James S K, Atar D, Badano L P, et al. ESC Guidelines for the Management of Acute Myocardial Infarction in Patients Presenting with ST-Segment Elevation: The Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society Of ... Eur Heart J 2012, 33:2569-2619.

Article Number 685835: Thygesen K, Alpert J S, Jaffe A S, Simoons M L, et al. Third Universal Definition of Myocardial Infarction. Eur Heart J 2012, 33:2551-2567.

Article Number 685724: Khanna D, Khanna P P, Fitzgerald J D, Singh M K, et al. 2012 American College of Rheumatology Guidelines for Management of Gout. Part 2: Therapy and Antiinflammatory Prophylaxis of Acute Gouty Arthritis. Arthritis Care Res 2012, 64:1447-1461.

Article Number 685723: Khanna D, Fitzgerald J D, Khanna P P, Bae S, et al. 2012 American College of Rheumatology Guidelines for Management of Gout. Part 1: Systematic Nonpharmacologic and Pharmacologic Therapeutic Approaches to Hyperuricemia. Arthritis Care Res 2012, 64:1431-1446.

Article Number 685655: Shulman S T, Bisno A L, Clegg H W, Gerber M A, et al. Clinical Practice Guideline for the Diagnosis and Management of Group a Streptococcal Pharyngitis: 2012 Update by the Infectious Diseases Society of America. Clin Infect Dis 2012, 55:E86-E102.

Article Number 685638: Shulman S T, Bisno A L, Clegg H W, Gerber M A, et al. Clinical Practice Guideline for the Diagnosis and Management of Group a Streptococcal Pharyngitis: 2012 Update by the Infectious Diseases Society of America. Clin Infect Dis 2012, 55:1279-1282.

Article Number 684643: Vahanian A, Alfieri O, Andreotti F, Antunes M J, et al. Guidelines on Management of Valvular Heart Disease (Version 2012): The Joint Task Force on Management of Valvular Heart Disease of the European Society of Cardiology (ESC) & European Association for Cardio-Thoracic Surgery (EACTS) …. Eur Heart J 2012, 33:2451-2496.


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