Company* |
Product | Description | Indication |
Status |
AUTOIMMUNE | ||||
Abbott |
Humira (FDA-approved) |
Adalimumab; fully human monoclonal antibody |
Moderate to severe chronic plaque psoriasis |
Submitted an sBLA and a Type II Variation to the EMEA seeking approval (4/2) |
Genelabs |
Prestara |
Oral drug that contains as the active ingredient highly purified prasterone |
Lupus |
Reached an agreement with the FDA on an SPA for a Phase III trial (4/3) |
CANCER | ||||
Enzon |
DepoCyt |
Cytarabine liposome injection |
Lymphomatous meningitis |
FDA granted full approval; the product was originally approved in 1999 under an accelerated process (4/20) |
Exagen |
eXagenBC |
DNA-based test designed to identify the risk of recurrence in breast cancer patients and allows physicians to predict prognosis outcome |
For breast cancer |
Filed for FDA review (4/5) |
Genta Inc. |
Genasense |
Oblimersen sodium injection |
Chronic lymphocytic leukemia |
Filed an appeal of the recent non-approvable decision by the FDA for its NDA (4/4) |
GPC Biotech |
Satraplatin |
Oral platinum compound |
Prostate cancer |
FDA accepted the NDA for satraplatin in combination with prednisone hormone-refractory prostate cancer patients whose prior chemotherapy has failed (4/16) |
Indevus |
Valstar (FDA-approved) |
Sterile solution removed from the market in 2002 due to stability issues |
Bladder cancer |
Submitted an sNDA seeking to reintroduce Valstar (4/19) |
Pharmacyclics |
Xcytrin |
Motexafin gadolinium; small molecule from the texaphyrin class designed to induce apoptosis |
Non-small-cell lung cancer with brain metastases |
Company filed an NDA for Xcytrin in combination with standard radiation therapy; the company has "filed over protest" since the the FDA previously refused to accept the NDA because of a failed primary endpoint (4/23) |
CARDIOVASCULAR | ||||
CSL Behring* |
Rhophylac RhO |
Immune globulin intravenous [human], an anti-D Rh immunoglobulin |
Immune thrombocyto-penic purpura |
FDA granted marketing approval (4/2) |
CENTRAL NERVOUS SYSTEM | ||||
Cephalon Inc. |
Nuvigil (modafinil) |
Armodafinil; single-isomer formulation of the active ingredient in Provigil |
Sleepiness associated with narcolepsy |
FDA decided Nuvigil is approvable following a standard safety update (4/2) |
SkyePharma plc |
REQUIP XL (FDA-approved as REQUIP) |
24-hour extended-release tablets; ropinirole HCl |
Parkinson's disease |
FDA accepted for filing the marketing application (4/13) |
Novalar |
NV-101 |
A fast-acting local dental anesthetic reversal agent; consists of the vasodilator phenotamine mesylate |
To restore normal sensation |
Submitted an NDA (4/10) |
DIABETES | ||||
Depomed Inc. |
Glumetza (FDA-approved) |
Metformin hydrochloride extended-release tablets |
Type II diabetes |
Filed a prior approval supplement seeking to market 1,000 mg strength tablets (4/2) |
INFECTION | ||||
Cangene Corp. |
HepaGam B |
Hyperimmune product |
To prevent hepatitis B recurrence following liver transplantation |
Won FDA approval in hepatitis B surface-antigen-positive liver transplant patients (4/6) |
Cepheid Inc. |
Xpert MRSA test |
It runs on the GeneXpert System to rapidly detect MRSA |
To detect Methicillin- resistant Staphylococcus aureus |
Received FDA clearance to market the test (4/18) |
CSL |
Influenza vaccine; thimerosal-free |
Influenza |
Submitted a BLA for an influenza vaccine, which would be made available in both a single-dose, thimerosal-free, pre-filled syringe and in multidose vials (4/3) |
|
Naryx Pharma |
SPRC-AB01 |
An antibiotic formulated for nasal inhalation |
Chronic sinusitis |
FDA granted fast-track designation (4/17) |
Pfizer Inc. |
Maraviroc |
A CCR5 antagonist |
HIV-1 |
FDA committee voted unanimously to recommend the approval of maraviroc for use along with other antiretroviral agents for treatment-experienced patients (4/25)
|
MISCELLANEOUS | ||||
Inspire |
AzaSite |
Azithromycin ophthalmic solution 1% |
Bacterial conjunctivitis |
FDA cleared AzaSite to treat the condition caused by susceptible isolates of CDC coryneform group G, Haemophilus influen- zae, Staphylococcus aureus, Streptococcus mitis group and Streptococcus pneumoniae (4/30) |
| ||||
Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
LSE = London Stock Exchange; NYSE = New York Stock Exchange; TSX = Toronto Stock Exchange. | ||||