Review Of Reviews: Drug Review Profiles 2013

Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2013.

Drug	Review Profile Stories
Teva Pharmaceuticals’ Granix (tbo-filgrastim)	(Also see "No Comparison: FDA Draws Bright Line Between BLA, Biosimilar Pathways In Tbo-filgrastim Review" - Pink Sheet, 20 Feb, 2013.) (Also see "The Perils Of A Pre-Filled Syringe: Device Issues Delayed Tbo-filgrastim" - Pink Sheet, 20 Feb, 2013.)
Sanofi’s Aubagio (teriflunomide)	(Also see "Aubagio Approval Reflects FDA’s Evolving View On Multiple Sclerosis Drugs" - Pink Sheet, 19 Mar, 2013.) (Also see "FDA Looked To Arava’s Safety Experience In Gauging Aubagio’s Risks" - Pink Sheet, 19 Mar, 2013.)
Genentech’s Kadcyla (ado-trastuzumab emtansine)	(Also see "Randomization Required: Liver Signal Necessitated Kadcyla Trial With Control Arm" - Pink Sheet, 16 Apr, 2013.) (Also see "Kadcyla Manufacturing Review Was A Production In Itself" - Pink Sheet, 16 Apr, 2013.) (Also see "Ado-Over: FDA Uses Prefix To Get Ahead Of Pull-Down Menu Problem" - Pink Sheet, 16 Apr, 2013.)
Salix Pharmaceuticals’ Fulyzaq (crofelemer)	(Also see "Fulyzaq Review Shows FDA Adapting Smoothly To Adaptive Trial Design" - Pink Sheet, 22 May, 2013.) (Also see "Botanical Review Team Develops “Post-CMC” Approach" - Pink Sheet, 22 May, 2013.) (Also see "A Question Of Identity: Drug & Botanical Perspectives On Manufacturing Clash In Fulyzaq Review" - Pink Sheet, 22 May, 2013.)
Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban)	(Also see "Eliquis Approval Delayed By Fraud, Dispensing Errors In Pivotal Trial" - Pink Sheet, 18 Jun, 2013.) (Also see "“Marginal” Mortality Benefit Belongs In Eliquis’ Label, But Not The Indication Statement, FDA Says" - Pink Sheet, 18 Jun, 2013.)
GlaxoSmithKline’s Breo Ellipta (fluticasone furoate/vilanterol)	(Also see "Two Claims Allow GSK To Show Benefit For Each Breo Component In COPD" - Pink Sheet, 23 Jul, 2013.) (Also see "Breo Inverts Traditional Path To COPD Indication For LABA Combinations" - Pink Sheet, 23 Jul, 2013.) (Also see "Breo Asthma NDA Remains Up In The Air" - Pink Sheet, 23 Jul, 2013.)
Johnson & Johnson’s Invokana (canagliflozin)	(Also see "FDA Used Invokana Review To Reflect On Diabetes CV Risk Policy" - Pink Sheet, 27 Aug, 2013.) (Also see "Bigger Is Better, FDA Tells J&J Over Invokana Outcomes Trial" - Pink Sheet, 27 Aug, 2013.)  (Also see "Invokana Development Directed By Mechanism Of Action" - Pink Sheet, 27 Aug, 2013.) (Also see "Diabetes Is Not For The Faint Of Heart" - Pink Sheet, 27 Aug, 2013.)
GlaxoSmithKline’s Mekinist (trametinib) and Tafinlar (dabrafenib)	(Also see "Technical Difficulties Prevented Priority Review Of GSK Melanoma Drugs" - Pink Sheet, 15 Oct, 2013.)  (Also see "A Short Summary Of Tafinlar and Mekinist NDA Deficiencies" - Pink Sheet, 15 Oct, 2013.) (Also see "The Magnitude Matters: GSK Approvals Show How To Use PFS After Other Drugs Show Survival" - Pink Sheet, 19 Nov, 2013.)  (Also see "FDA Considers Toxicity Profiles As Meeting Unmet Need In Melanoma" - Pink Sheet, 19 Nov, 2013.)
Ariad Pharmaceuticals’ Iclusig (ponatinib)	(Also see "Iclusig Experience Reflects Regulatory Risk Inherent With Accelerated Approval" - Pink Sheet, 17 Dec, 2013.) (Also see "Ariad Took Dismissive View Of CV Events In Iclusig Labeling Proposals" - Pink Sheet, 17 Dec, 2013.)