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Drug Information Resources

IDIS Logo   IDIS Monthly Update Information - April 2013

NEW DRUG TERM
ARGININE DEIMINASE, PEGYLATED
AVE-1642
AZD-1386
DICYCLOPLATIN
ELOBIXIBAT
EV-077
F-16-SIP, I 124
FPEB, F18-
ICOSAPENT ETHYL
IMEGLIMIN
INTERFERON ALFA KINOID
INTETUMUMAB
IODINE I 123 MIP-1095
IOFOLASTAT I 123
ISO-I, F18-
MENINGOCOCCAL B VACCINE
MSDC-0160
ONABOTULINUMTOXINA
PEXACERFONT
PHENAZEPAM
QBG-10
SELEXIPAG
SIPOGLITAZAR
TELAPRISTONE
TG-4010
TRIBENDIMIDINE

CODE
44000032
82000576
28081306
10040819
56120090
20120681
78040432
78042005
24060103
68200459
14000210
10120306
78040430
78040431
78042004
80120110
68200461
92000394
92000393
28240262
14000088
24120120
68200460
92000296
10120642
8080052


FDA APPROVAL PACKAGES

Article Numbers 694653-694668: Mipomersen Sodium, Kynamro, FDA Approval Package for NDA 203568. FDA Approval Package 2013.

Article Numbers 694453-694469: Pomalidomide, Pomalyst, FDA Approval Package for NDA 204026. FDA Approval Package 2013.

Article Numbers 694440-694452: Alogliptin, Nesina, FDA Approval Package for NDA 022271. FDA Approval Package 2013.

Article Numbers 694334-694348: Bedaquiline Fumarate, Sirturo, FDA Approval Package for NDA 204384. FDA Approval Package 2012.

Article Numbers 694320-694333: Apixaban, Eliquis, FDA Approval Package for NDA 202155. FDA Approval Package 2012.

Article Numbers 694306-694319: Lomitapide, Juxtapid, FDA Approval Package for NDA 203858. FDA Approval Package 2012.

Article Numbers 694275-694290: Crofelemer, Fulyzaq, FDA Approval Package for NDA 202292. FDA Approval Package 2012.

Article Numbers 694262-694274: Icosapent Ethyl, Vascepa, FDA Approval Package for NDA 202057. FDA Approval Package 2012.


FDA PEDIATRIC REVIEWS

Article Numbers 694684-694687: Adapalene, Differin, FDA Pediatric Review for NDA 22-502. FDA Pediatric Review 2010.

Article Numbers 694680-694683: Adalimumab, Humira, FDA Pediatric Review for SBLA 125057/114. FDA Pediatric Review 2008.

Article Numbers 694677-694679: Acyclovir; Hydrocortisone, Xerese, FDA Pediatric Review for NDA 022436. FDA Pediatric Review 2009.

Article Numbers 694673-694676: Alfuzosin Hydrochloride, Uroxatral, FDA Pediatric Review for NDA 21287 S-016. FDA Pediatric Review 2010.

Article Numbers 694669-694672: Adefovir Dipivoxil, Hepsera, FDA Pediatric Review for NDA 21-449 Se5-011. FDA Pediatric Review 2007.


ADVISORY COMMITTEE MEETINGS

Article Numbers 694299-694305: Medical Imaging Drugs Advisory Committee Meeting, February 14, 2013. FDA Advisory Committee 2013.

Article Numbers 694292-694298: Endocrinologic and Metabolic Drugs Advisory Committee Meeting, January 10, 2013. FDA Advisory Committee 2013.


BLACK BOX WARNING

Article Number 694291: Telaprevir Film-Coated Tablets: FDA Black Box Warning. 2012.


CONTINUING EDUCATION ARTICLES

Article Number 694725: Anonymous. Mitomycin Solution (Mitosol) for Glaucoma Surgery (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 694723-694725]. Med Lett Drugs Ther 2013, 55:24.

Article Number 694724: Anonymous. Budesonide (Uceris) for Ulcerative Colitis (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 694723-694725]. Med Lett Drugs Ther 2013, 55:23.

Article Number 694723: Anonymous. A New Low-Dose Levonorgestrel-Releasing IUD (Skyla) (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 694723-694725]. Med Lett Drugs Ther 2013, 55:21-22.

Article Number 694722: Anonymous. In Brief: Two New Seasonal Influenza Vaccines (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 694720-694722]. Med Lett Drugs Ther 2013, 55:12.

Article Number 694721: Anonymous. Quillivant XR—An Extended-Release Oral Suspension of Methylphenidate (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 694720-694722]. Med Lett Drugs Ther 2013, 55:10-11.

Article Number 694720: Anonymous. Apixaban (Eliquis)—A New Oral Anticoagulant for Atrial Fibrillation (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 694720-694722]. Med Lett Drugs Ther 2013, 55:9-10.

Article Number 694719: Anonymous. Aclidinium Bromide (Tudorza Pressair) for COPD (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 694718 and 694719]. Med Lett Drugs Ther 2012, 54:99-100.

Article Number 694718: Anonymous. Antiviral Drugs for Influenza 2012-2013 (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 694718 and 694719]. Med Lett Drugs Ther 2012, 54:97-98.

Article Number 694599: Cada D J, Demaris K, Levien T L, Baker D E. Teriflunomide (0.15 CEU). Hosp Pharm 2013, 48:231-240.

Article Number 694168: Anonymous. Antiviral Drugs (0.2 CEU). Treat Guidel Med Lett 2013, 11:19-30.

Article Number 693742: Anonymous. Misoprostol for Miscarriage (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 693741 and 693742]. Med Lett Drugs Ther 2013, 55:19-20.

Article Number 693741: Anonymous. Drugs for Hypertriglyceridemia (0.1 CEU) [IDIS Note: The 1.0 Hour of CE Credit is for All Articles in this Issue, Article Numbers 693741 and 693742]. Med Lett Drugs Ther 2013, 55:17-19.

Article Number 693331: Cada D J, Levien T L, Baker D E. Linaclotide (0.15 CEU). Hosp Pharm 2013, 48:143-152.


PRIORITY CLINICAL PRACTICE GUIDELINES

Article Number 694172: Anonymous. American Diabetes Association: Clinical Practice Recommendations 2013. Diabetes Care 2013, 36:S1-S110.


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