FDA Submissions, Approvals And Other Actions: April 2007
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)
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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) |
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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. | ||||