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Drug Information Resources

IDIS Logo   IDIS Monthly Update Information - May 2014

NEW DRUG TERM
AZD-2624
BIOLOGICAL TISSUE ISOLATE
BMS-936557
FRESOLIMUMAB
GALUNISERTIB
MAGNESIUM THREONATE
MPDL-3280-A
OMBITASVIR
TC 99M ETARFOLATIDE

CODE
28161222
82000014
82000595
82000594
10121070
40120097
10121069
8180139
78040279



DRUG NAME/CODE CHANGES

OLD TERM & CODE
ABT-333 8180127
BKM-120 10121008

NEW TERM & CODE
DASABUVIR 8180127
BUPARLISIB 10121008


FDA APPROVAL PACKAGES

Article Numbers 715676-715691: Miltefosine, Impavido, FDA Approval Package for NDA 204684. FDA Approval Package 2014.

Article Numbers 715335-715350: Apremilast, Otezla, FDA Approval Package for NDA 205437. FDA Approval Package 2014.

Article Numbers 715319-715334: Metreleptin, Myalept, FDA Approval Package for BLA 125390. FDA Approval Package 2014.

Article Numbers 715304-715318: Florbetaben F18 Injection, Neuraceq, FDA Approval Package for NDA 204677. FDA Approval Package 2014.


ADVISORY COMMITTEE MEETINGS


Article Numbers 715375-715384: Anti-Infective Drugs Advisory Committee Meeting, March 31, 2014. FDA Advisory Committee 2014.

Article Numbers 715368-715374: Endocrinologic and Metabolic Drugs Advisory Committee Meeting, April 1, 2014. FDA Advisory Committee 2014.

Article Numbers 715361-715367: Cardiovascular and Renal Drugs Advisory Committee Meeting, March 27, 2014. FDA Advisory Committee 2014.


BLACK BOX WARNINGS

Article Number 715360: Revised (3/7/2014): Valproic Acid (And Derivatives): FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 708360]. 2014.

Article Number 715359: Revised (03/06/2014): Rivaroxaban: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 708352]. 2014.

Article Number 715358: Revised (1/17/2014): Losartan: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 561110]. 2014.

Article Number 715357: Revised (2/10/2014: Eltrombopag Olamine: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 614734]. 2014.

Article Number 715356: Revised (2/25/2014): Ketoconazole: FDA Black Box Warning [IDIS Note: to View Outdated Warning See Article 708364]. 2014.


CONTINUING EDUCATION ARTICLES

Article Number 714871: Lucio S. Clinical and Formulary Considerations for Biosimilars (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 714870 and 714871]. Hosp Pharm 2014, 49:S6-S12.

Article Number 714870: Mcbride A. Evolving Biosimilars Marketplace (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 714870 and 714871]. Hosp Pharm 2014, 49:S1-S5.

Article Number 714566: Meyer K C. Copd 2013: An Update on Treatment and Newly Approved Medications for Pharmacists (0.2 CEU). J Am Pharm Assoc 2013, 53:E219-E231.

Article Number 714383: Cada D J, Baker D E. Conjugated Estrogens and Bazedoxifene (0.15 CEU). Hosp Pharm 2014, 49:273-283.


PRIORITY CLINICAL PRACTICE GUIDELINES

Article Number 715692: Anonymous. Full Guideline. Pressure Ulcers: Prevention and Management of Pressure Ulcers. NICE Clinical Guideline No. 179 (Ref Art 715693). NICE Clin Guidel 2014.


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