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o Zactima - application withdrawn due to no overall survival advantage; approval not expected before 2011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
o Anonymity is guaranteed (if preferred), see the rules for more details