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Drug Information Resources

Notice: IDIS database discontinuation December 31, 2014.   Read more.

IDIS Logo   IDIS Monthly Update Information - December 2013

NEW DRUG TERM
AMT, C11-
ANFIBATIDE
BMS-962476
CAPLACIZUMAB
NETAZEPIDE
OPICAPONE
PBR-111, F18-
RHMPV-SH
SOTATERCEPT

CODE
78042013
20120682
24060105
82000822
56260042
44100116
78042011
80080013
14000093



DRUG NAME/CODE CHANGES

OLD TERM & CODE
AMG-403 82000548
EKB-569 10120855
IPP-201101 14000061
PBR-06, F 18 36680071
YM-155 10120898

NEW TERM & CODE
FULRANUMAB 82000550
PELITINIB 10120855
FORIGERIMOD 14000061
PBR-06, F18- 78042012
SEPANTRONIUM BROMIDE 10120898


FDA APPROVAL PACKAGES

Article Numbers 708369-708383: Macitentan Tablets, Opsumit, FDA Approval Package for NDA 204410. FDA Approval Package 2013.

Article Numbers 708277-708291: Riociguat, Adempas, FDA Approval Package for NDA 204819. FDA Approval Package 2013.

Article Numbers 708262-708276: Vortioxetine Hydrobromide, Brintellix, FDA Approval Package for NDA 204447. FDA Approval Package 2013.


ADVISORY COMMITTEE MEETINGS

Article Numbers 708105-708111: Antiviral Drugs Advisory Committee Meeting, October 25, 2013. FDA Advisory Committee 2013.

Article Numbers 708098-708104: Antiviral Drugs Advisory Committee Meeting, October 24, 2013. FDA Advisory Committee 2013.

Article Numbers 708091-708097: Anti-Infective Drugs Advisory Committee Meeting, October 18, 2013. FDA Advisory Committee 2013.

Article Numbers 708085-708090: Anti-Infective Drugs Advisory Committee Meeting, October 17, 2013. FDA Advisory Committee 2013.

Article Numbers 708078-708084: Endocrinologic and Metabolic Drugs Advisory Committee Meeting, October 16, 2013. FDA Advisory Committee 2013.


BLACK BOX WARNING

Article Number 708368: Revised (10/21/2013): Alvimopan: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 637387]. 2013.

Article Number 708367: Revised (10/23/2013): Enoxaparin: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 630721]. 2013.

Article Number 708366: Revised (9/27/2013): Nilotinib: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 627306]. 2013.

Article Number 708365: Revised (9/24/2013): Rituximab: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 571505]. 2013.

Article Number 708364: Revised (7/25/2013): Ketoconazole: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 559511]. 2013.

Article Number 708363: Revised (6/24/2013): Immune Globulin (Human ): FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 559683]. 2013.

Article Number 708362: Revised (6/24/2013): Idursulfase: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 569482]. 2013.

Article Number 708361: Revised (5/16/2013): Estradiol (Transdermal): FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 680581]. 2013.

Article Number 708360: Revised (7/31/2013): Valproic Acid (And Derivatives): FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 555190]. 2013.

Article Number 708359: Revised (7/31/2013): Divalproex Sodium: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 561301]. 2013.

Article Number 708358: Acetaminophen Injection: FDA Black Box Warning. 2013.

Article Number 708357: Norethindrone/Ethinyl Estradiol: FDA Black Box Warning. 2013.

Article Number 708356: Norgestimate/Ethinyl Estradiol: FDA Black Box Warning. 2013.

Article Number 708355: Desogestrel/Ethinyl Estradiol: FDA Black Box Warning. 2013.

Article Number 708354: Ezogabine: FDA Black Box Warning. 2013.

Article Number 708353: Tigecycline: FDA Black Box Warning. 2013.

Article Number 708352: Rivaroxaban: FDA Black Box Warning. 2013.

Article Number 708351: Ofatumumab: FDA Black Box Warning. 2013.

Article Number 708350: Codeine Sulfate: FDA Black Box Warning. 2013.


CONTINUING EDUCATION ARTICLES

Article Number 708459: Anonymous. Topiramate Extended-Release (Trokendi XR) for Epilepsy (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for These Articles in this Issue, Article Numbers 708457-708459]. Med Lett Drugs Ther 2013, 55:87-88.

Article Number 708458: Anonymous. Belotero Balance for Wrinkles and Folds (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for These Articles in this Issue, Article Numbers 708457-708459]. Med Lett Drugs Ther 2013, 55:86-87.

Article Number 708457: Anonymous. Paroxetine (Brisdelle) for Hot Flashes (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for These Articles in this Issue, Article Numbers 708457-708459]. Med Lett Drugs Ther 2013, 55:85-86.

Article Number 708179: Cada D J, Demaris K, Levien T L, Baker D E. Doxylamine Succinate/Pyridoxine Hydrochloride (0.15 CEU). Hosp Pharm 2013, 48:762-766.


PRIORITY CLINICAL PRACTICE GUIDELINES

Article Number 707907: Authors/Task Force M, Ryden L, Grant P J, Anker S D, et al. ESC Guidelines on Diabetes, Pre-Diabetes, and Cardiovascular Diseases Developed in Collaboration with the EASD: The Task Force on Diabetes, Pre-Diabetes, and Cardiovascular Diseases of the European Society Of .... Eur Heart J 2013, 34:3035-3087J.

Article Number 707906: Task Force Members, Montalescot G, Sechtem U, Achenbach S, et al. 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease: The Task Force on the Management of Stable Coronary Artery Disease of the European Society of Cardiology. Eur Heart J 2013, 34:2949-3003G.

Article Number 707272: Yancy C W, Jessup M, Bozkurt B, Butler J, et al. 2013 ACCF/AHA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013, 62:1495-1539.

Article Number 707179: Writing Committee Me, Yancy C W, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2013, 128:E240-E327.


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