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Drug Information Resources

IDIS Logo   IDIS Monthly Update Information - July 2013

NEW DRUG TERM
ABT-288
ALFATIDE, F 18
ASKP-1240
BAY-867548
CALCIUM L-THREONATE
CESIUM CARBONATE
CGTG-102
CNTO-5825
GSK-1144814
ICMT-11, F18-
INCLACUMAB
LCL-161
LULICONAZOLE
MBL-HCV1
MEDI-546
METHANESULFONYL FLUORIDE
SCH-900948
SPHAERALCEA ANGUSTIFOLIA
TBO-FILGRASTIM

CODE
95000355
36680132
82000579
78042007
40121214
92000397
10121058
82000582
28160397
78042006
82000578
10121059
8120529
82000580
82000581
12040036
68200879
92510298
14000091



DRUG NAME/CODE CHANGES

OLD TERM & CODE
EP-01572 68280018
ORG-25935 28161221

NEW TERM & CODE
MACIMORELIN 68280018
SCH-900435 28161221


FDA APPROVAL PACKAGES

Article Numbers 699881-699896: Fluticasone Furoate and Vilanterol Inhalation Powder, Breo Ellipta, FDA Approval Package for NDA 204275. FDA Approval Package 2013.

Article Numbers 699384-699398: Technetium Tc 99m Tilmanocept, Lymphoseek Kit, FDA Approval Package for NDA 202207. FDA Approval Package 2013.

Article Numbers 699369-699383: Gadoterate Meglumine, Dotarem, FDA Approval Package for NDA 204781. FDA Approval Package 2013.


FDA PEDIATRIC REVIEWS

Article Numbers 700020-700026: Aripiprazole, Abilify, FDA Pediatric Review for NDA 21-436/S-017, 21-713/S-012, 21-729/S-004, and 21-866/2-004. FDA Pediatric Review 2007.

Article Numbers 700017-700019: Atazanavir, Reyataz, FDA Pediatric Review for NDA 21-567/015. FDA Pediatric Review 2008.


ADVISORY COMMITTEE MEETINGS

Article Numbers 700004-700010: Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee June 5-6, 2013. FDA Advisory Committee 2013.

Article Numbers 699679-699685: Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee, May 3, 2013. FDA Advisory Committee 2013.

Article Numbers 699672-699678: Peripheral and Central Nervous System Drugs Advisory Committee Meeting, May 22, 2013. FDA Advisory Committee 2013.


CONTINUING EDUCATION ARTICLES

Article Number 700199: Anonymous. Drugs for Psychiatric Disorders (0.2 CEU). Treat Guidel Med Lett 2013, 11:53-64.

Article Number 700144: Hanson R. Current and Emerging Therapies for Pulmonary Arterial Hypertension (0.15 CEU) [IDIS Note: The 1.5 Hours of CE Credit is for Both Articles in this Issue, Article Numbers 700143 and 700144]. Hosp Pharm 2013, 48:S7-S14.

Article Number 700143: Schuller D. Clinical Overview of Pulmonary Arterial Hypertension (0.15 CEU) [IDIS Note: The 1.5 Hours of CE Credit is for Both Articles in this Issue, Article Numbers 700143 and 700144]. Hosp Pharm 2013, 48:S1-S6.

Article Number 700142: Anonymous. Lubiprostone (Amitiza) for Opioid-Induced Constipation (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for These Articles in this Issue, Article Numbers 700141 and 700142]. Med Lett Drugs Ther 2013, 55:47-48.

Article Number 700141: Anonymous. Dimethyl Fumarate (Tecfidera) for Multiple Sclerosis (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for These Articles in this Issue, Article Numbers 700141 and 700142]. Med Lett Drugs Ther 2013, 55:45-47.

Article Number 700139: Anonymous. Omalizumab (Xolair) for Chronic Urticaria (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for These Articles in this Issue, Article Numbers 700138 and 700139]. Med Lett Drugs Ther 2013, 55:43-44.

Article Number 700138: Anonymous. Alogliptin (Nesina) for Type 2 Diabetes (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for These Articles in this Issue, Article Numbers 700138 and 700139]. Med Lett Drugs Ther 2013, 55:41-43.


PRIORITY CLINICAL PRACTICE GUIDELINES

Article Number 700015: Anonymous. Full Guideline. Ulcerative Colitis: Management in Adults, Children and Young People. NICE Clinical Guideline No. 166 (Ref Art 700016). NICE Clin Guidel 2013.

Article Number 700013: Anonymous. Full Guideline. Hepatitis B (Chronic): Diagnosis and Management of Chronic Hepatitis B in Children, Young People and Adults. NICE Clinical Guideline No. 165 (Ref Art 700014). NICE Clin Guidel 2013.

Article Number 700011: Anonymous. Full Guideline. Familial Breast Cancer: Classification and Care of People At Risk of Familial Breast Cancer & Management of Breast Cancer Related Risks in People with a Family History ...NICE Clinical Guideline No. 164 (Ref #700012). NICE Clin Guidel 2013.

Article Number 699903: Anonymous. Full Guideline. Diagnosis and Management of Suspected Idiopathic Pulmonary Fibrosis. NICE Clinical Guideline No. 163 (Ref Art 699904). NICE Clin Guidel 2013.

Article Number 699901: Anonymous. Full Guideline. Falls: Assessment and Prevention of Falls in Older People. NICE Clinical Guideline No. 161 (Ref Art 699902). NICE Clin Guidel 2013.

Article Number 699899: Anonymous. Full Guideline. Feverish Illness in Children: Assessment and Initial Management in Children Younger Than 5 Years. NICE Clinical Guideline No. 160 (Ref Art 699900). NICE Clin Guidel 2013.

Article Number 699897: Anonymous. Full Guideline. Social Anxiety Disorder: Recognition, Assessment and Treatment. NICE Clinical Guideline No. 159 (Ref Art 699898). NICE Clin Guidel 2013.


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