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Drug Information Resources

IDIS Logo   IDIS Monthly Update Information - May 2013

NEW DRUG TERM
BARACITINIB
BAY-869766
BETA ALANINE
BRYOPHYLLUM PINNATUM
CHI LOB 7-4
CTL-019
GC-33
GLPG-0259
GRN-1005
INDISETRON
JX-594
LEVOMILNACIPRAN
MOZAVAPTAN
MP-0112
MTP-131
MVA-EL
ORG-43553
ORG-43902
OSI-930
PPA-904
PRX-302
TABALUMAB
TC 99M TILMANOCEPT
TONABERSAT
V-710 S AUREUS VACCINE

CODE
14000089
10121053
40200452
92510296
10120308
10121054
10120307
14000090
10121055
56220040
10121051
28160398
40280052
14000519
14000117
10120643
68180017
68180018
10121052
92000396
92000395
82000577
78040277
28081307
80120111



DRUG NAME/CODE CHANGES

OLD TERM & CODE
BMS-936558 10120273
R-1626 8180102
TRASTUZUMAB EMTANSINE 82000541

NEW TERM & CODE
NIVOLUMAB 10120273
BALAPIRAVIR 8180102
ADO-TRASTUZUMAB EMTANSINE 82000541


FDA APPROVAL PACKAGES

Article Numbers 696416-696429: Dimethyl Fumarate, Tecfidera, FDA Approval Package for NDA 204063. FDA Approval Package 2013.

Article Numbers 695550-695563: Ospemifene, Osphena, FDA Approval Package for NDA 203505. FDA Approval Package 2013.


FDA PEDIATRIC REVIEWS

Article Numbers 696440-696442: Amoxicillin/Clavulanate Potassium, Augmentin XR, FDA Pediatric Review of NDA 50-785/S012. FDA Pediatric Review 2010.

Article Numbers 696438-696439: Almotriptan Malate, Axert, FDA Pediatric Review for NDA 21-001 (011). FDA Pediatric Review 2009.

Article Numbers 696434-696437: Anastrozole, Arimidex, FDA Pediatric Review of NDA 22-214. FDA Pediatric Review 2008.

Article Numbers 696430-696433: Amoxicillin, Moxatag, FDA Pediatric Review of NDA 50-813. FDA Pediatric Review 2008.


ADVISORY COMMITTEE MEETINGS

Article Numbers 695543-695549: Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee, March 5, 2013. FDA Advisory Committee 2013.

Article Numbers 695536-695542: Pulmonary-Allergy Drugs Advisory Committee Meeting, January 30, 2013. FDA Advisory Committee 2013.

Article Numbers 695529-695535: Drug Safety and Risk Management Advisory Committee Meeting, January 24-25, 2013. FDA Advisory Committee 2013.

Article Numbers 695452-695458: Psychopharmacologic Drugs Advisory Committee Meeting, March 21, 2013. FDA Advisory Committee 2013.

Article Numbers 695443-695451: Reproductive Health Drugs Advisory Committee Meeting, March 4, 2013. FDA Advisory Committee 2013.

Article Numbers 695439-695442: Vaccines and Related Biological Products Advisory Committee Meeting, February 27, 2013. FDA Advisory Committee 2013.


CONTINUING EDUCATION ARTICLES

Article Number 696450: Anonymous. Botox for Overactive Bladder (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for These Articles in this Issue, Article Numbers 696449 and 696450]. Med Lett Drugs Ther 2013, 55:31-32.

Article Number 696449: Anonymous. Teduglutide Injection (Gattex) for Short Bowel Syndrome (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for These Articles in this Issue, Article Numbers 696449 and 696450]. Med Lett Drugs Ther 2013, 55:29-30.

Article Number 696413: Anonymous. Drugs for Pain (0.2 CEU). Treat Guidel Med Lett 2013, 11:31-42.

Article Number 695950: Gerhart D C. Infusion Device Integration and Its Impact on Pharmacy (0.15 CEU) [IDIS Note: The 1.5 Hours of CE Credit is for All Articles in this Issue, Article Numbers 695948-695950]. Hosp Pharm 2013, 48:S9-S11.

Article Number 695949: Prevost R R. Pharmacist's Role in Integrated Infusion Management: Medication Safety Perspective (0.15 CEU) [IDIS Note: The 1.5 Hours of CE Credit is for All Articles in this Issue, Article Numbers 695948-695950]. Hosp Pharm 2013, 48:S5-S8.

Article Number 695948: O'Shea K L. Infusion Management: Working Smarter, Not Harder (0.15 CEU) [IDIS Note: The 1.5 Hours CE Credit is for All Articles in this Issue, Article Numbers 695948-695950]. Hosp Pharm 2013, 48:S1-S4.

Article Number 695185: Anonymous. In Brief: FDA Azithromycin Warning (0.1 CEU). Med Lett Drugs Ther 2013, 55:28.

Article Number 695184: Anonymous. Raxibacumab for Anthrax (0.1 CEU). Med Lett Drugs Ther 2013, 55:27-28.

Article Number 695183: Anonymous. 2 New Drugs for Homozygous Familial Hypercholesterolemia (0.1 CEU). Med Lett Drugs Ther 2013, 55:25-27.


PRIORITY CLINICAL PRACTICE GUIDELINES

Article Number 696085: Dellinger R P, Levy M M, Rhodes A, Annane D, et al. Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock, 2012. Intensive Care Med 2013, 39:165-228.

Article Number 695572: Anonymous. Full Guideline. Antisocial Behaviour and Conduct Disorders in Children and Young People: Recognition, Intervention and Management. NICE Clinical Guideline No. 158 (Ref Art 695573). NICE Clin Guidel 2013.

Article Number 695570: Anonymous. Full Guideline. Hyperphosphataemia in Chronic Kidney Disease: Management of Hyperphosphataemia in Patients with Stage 4 or 5 Chronic Kidney Disease. NICE Clinical Guideline No. 157 (Ref Art 695571). NICE Clin Guidel 2013.

Article Number 695568: Anonymous. Full Guideline. Fertility: Assessment and Treatment for People with Fertility Problems. NICE Clinical Guideline No. 156 (Ref Art 695569). NICE Clin Guidel 2013.

Article Number 695566: Anonymous. Full Guideline. Psychosis and Schizophrenia in Children and Young People: Recognition and Management. NICE Clinical Guideline No. 155 (Ref Art 695567). NICE Clin Guidel 2013.

Article Number 695564: Anonymous. Full Guideline. Ectopic Pregnancy and Miscarriage: Diagnosis and Initial Management in Early Pregnancy of Ectopic Pregnancy and Miscarriage. NICE Clinical Guideline No. 154 (Ref Art 695565). NICE Clin Guidel 2012.

Article Number 695520: Vestbo J, Hurd S S, Agusti A G, Jones P W, et al. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease: Gold Executive Summary. Am J Resp Crit Care Med 2013, 187:347-365.


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