Company* |
Product |
Description |
Indication |
Status |
| ||||
CANCER | ||||
|
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Debiopharm |
Trelstar LA |
Luteinizing hormone- releasing hormone agonist, triptorelin pamoate |
Advanced-stage prostate cancer |
FDA granted marketing approval (7/5) |
|
||||
IDEC |
Zevalin |
Mouse monoclonal antibody targeted against the CD20 antigen and conjugated to a yttrium-90 radioisotope; administered with Rituxan |
Non-Hodgkin's lymphoma |
Zevalin will be reviewed by the Oncologic Drugs Advisory Committee of the FDA on Sept. 11 (7/23) |
|
||||
Matrix |
IntraDose Injectable Gel |
Biodegradable gel containing cisplatin and epinephrine |
Head and neck cancer |
The Oncologic Drugs Advisory Committee of the FDA will review IntraDose on Sept. 10 (7/24) |
|
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CARDIOVASCULAR |
||||
|
||||
Corvas |
rNAPc2 |
Recombinant nematode anticoagulant protein C2 |
Deep-vein thrombosis |
Corvas' Phase III trial is delayed due to talks with the FDA concerning development (7/24) |
|
||||
Scios Inc. |
Natrecor |
Intravenous treatment; recombinant form of B- type natriuretic peptide |
Congestive heart failure |
Company received an approvable letter from the FDA (7/10); FDA said the preapproval inspection was completed (7/19) |
|
||||
Texas |
Argatroban |
Anticoagulant; synthetic direct thrombin inhibitor that blocks the activity of thrombin |
Thrombosis associated with heparin-induced thrombocytopenia |
FDA issued an approvable letter for a supplemental NDA for Argatroban (7/20) |
|
||||
CENTRAL NERVOUS SYSTEM |
||||
|
||||
Immunex |
Enbrel (FDA- approved) |
Etanercept; tumor necrosis factor receptor |
Psoriatic arthritis |
Company filed a supplemental BLA to use Enbrel with or without methotrexate (7/17) |
|
||||
DIABETES |
||||
|
||||
Amylin |
Symlin |
Pramlintide, a synthetic analogue of the human hormone amylin |
Type I and Type II diabetes |
The Endocrinologic and Metabolic Drugs Advisory Committee voted against recommending the product for approval (7/26) |
|
||||
INFECTION |
||||
|
||||
Enzon Inc. |
PEG-Intron Redipen Single-dose Delivery System |
Peginterferon alfa-2b; longer-acting form of Intron A injection that uses pegylated technology |
Chronic hepatitis C |
Companies submitted a supplemental BLA (7/3) |
|
||||
Aviron Inc. |
FluMist |
Intranasal vaccine |
Flu |
The Vaccines and Related Biological Products Advisory Committee said the safety data is not adequate for it to recommend approval, although the efficacy data was adequate (7/27) |
|
||||
Enzon Inc. |
Rebetol |
Ribavirin capsules |
Chronic hepatitis C |
Companies were granted marketing approval for Rebetol as a separately marketed product for use only in combination with Intron A injection; Rebetol was approved only as a component of Rebetron combination therapy and Intron A in a single package (7/26) |
|
||||
ViroPharma |
Picovir |
Pleconaril; antiviral drug; inhibits the function of the picornavirus capsid |
Common cold |
Company submitted an NDA (7/31) |
|
||||
MISCELLANEOUS | ||||
|
||||
Anika |
Shellgel |
Hyaluronic acid-based viscoelastic product |
For protecting eye tissue and maintaining eye shape during ophthalmic surgery |
Anika received premarket approval from the FDA for Shellgel (7/16) |
|
||||
Genentech |
Xolair |
Omalizumab |
Asthma and seasonal allergic rhinitis |
FDA said the BLA requires more data (7/10) |
|
||||
Novavax |
Estrasorb |
Estrogen replacement therapy |
Symptomatic menopause |
Company submitted an NDA (7/1) |
|
||||
Orphan |
Xyrem |
Sodium oxybate |
Cataplexy related to narcolepsy |
FDA issued an approvable letter for Xyrem (7/3) |
|
||||
Ortec |
OrCel |
Substitute engineered skin |
Burns |
The General and Plastic Surgery Devices Advisory Panel of the FDA unanimously recommended approval (7/17) |
|
||||
Xenova |
TA-CD |
Anti-cocaine addiction vaccine |
Cocaine addiction |
FDA released the product candidate from clinical hold (7/9) |
|
||||
Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; NYSE = New York Stock Exchange | ||||
BLA = Biologics License Application; NDA = New Drug Application | ||||
