Everything You Need to Know About Specialty Pipeline between 10/2009 to 3/2010

[diana.papshev]

DETAILS:

Please click on the product name to view up-to-date details captured by DrugPipelineForecast

Cardiovascular:
Expected approvals in 4Q 2009

o Lucassin

CNS:
Expected approvals in 4Q 2009

o Ampligen - will likely not be reviewed until outstanding NDA queries are resolved

Dermatologic:
Expected approvals in 4Q 2009

o polidocanol

Expected approvals in 1Q 2010

o azfibrocel-T (formerly Isolagen Therapy)

Enzyme replacements/Modifiers:
Expected approvals in 4Q 2009

o Kalbitor
o Xiaflex

Immunologics:
Expected approvals in 4Q 2009

o adenovirus types 4/7
o Cervarix - FDA approved 10/09
o fampridine SR
o Prevnar-13
o Prograf MR
o Prolia- (Complete response letter received 10/09- may delay approval)

Expected approvals in 1Q 2010

o ABthrax - (Complete response letter received 11/09- may delay approval)
o Actemra
o Menveo
o Mylinax

Oncology:
Expected approvals in 4Q 2009

o Arzerra- FDA approved 10/09

Expected approvals in 1Q 2010

o Zactima - application withdrawn due to no overall survival advantage; approval not expected before 2011

Latest updates are captured in the Specialty Pipeline Forecast as of September 2009

For more information, longer-term pipeline, or to search for additional drugs, please see DrugPipelineForecast.

About DrugPipelineForecast:
DrugPipelineForecast is a tool developed specifically for managed care professionals to address their unique needs. This is a site which can help you track late-phase pipeline:

o Products in late phase III to approval stages
o All types of information for an in-depth review
o Tabulated format for a quick analysis
o Search and filtering capabilities
o Default and customized reports
o Frequent updates

To access DrugPipelineForecast at no charge (for those who are currently employed by a health plan, PBM, specialty pharmacy, IPA, employer/benefits consultant), you must be a registered user of DrugManagementForum (click here to register)

About DrugManagementForum:
DrugManagementForum is dedicated to the managed care pharmacy and medical policy community, allowing you to connect and share your ideas and solutions to common problems and experiences. It offers a place for users and experts to post questions and comments that are relevant to your practice in the managed care setting.

Benefits of registering with DrugManagementForum:

o Offers managed care professionals to connect and share ideas/solutions to common problems and experiences in drug benefit management
o Objective, unbiased content without a commercial agenda (no pharma sponsorship)
o Exclusive only for those who are currently employed by a health plan, PBM, specialty pharmacy, IPA, employer/benefits consultant, or another organization that is responsible for managing healthcare coverage (those in academia and benefit consulting can also join)
o Free and includes access to the DrugPipelineForecast
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[chantell.reagan]

Here are 2 recently approved drugs that were not included in this forecast: Votrient (pazopanib) and Prolastin-C (Alpha1-Proteinase Inhibitor [Human] (see: FDA update on brand drugs for October 22, 2009)