Company |
Product |
Description |
Indication |
Status (Date) |
CANCER | ||||
Alza Corp. |
Doxil (FDA-approved) |
Doxorubicin HCl liposome injection |
Refractory ovarian cancer |
Oncologic Drugs Advisory Committee recommended approval of supplemental NDA (6/8); cleared for marketing (6/29) |
Coulter Pharmaceutical Inc. and SmithKline Beecham plc (U.K.; NYSE:SBH) |
Bexxar |
Iodine I-131 tositumomab; murine monoclonal antibody against CD20 antigen on B cells, labeled with I-131 |
Relapsed or refractory, low-grade or transformed lowgrade B-cell non-Hodgkin's lymphoma |
Submitted BLA (6/30) |
Fujirebio Diagnostics Inc. (unit of Fujirebio Inc.; Japan) |
CA19-9 RIA test kit |
Detects CA19-9 antigen in blood serum using monoclonal antibodies |
Diagnostic adjunct to radiological imaging techniques |
Submitted product development protocol (6/9) |
Ligand Pharmaceuticals Inc. |
Targretin capsules |
Bexarotene; synthetic retinoid analogue that selectively activates retinoid X receptors; oral formulation |
Early-stage cutaneous T-cell lymphoma |
Submitted NDA (6/23) |
Sugen Inc. | SU-5416 | Small-molecule angiogenesis inhibitor that blocks the signaling pathway of the vascular endothelial growth factor receptor | Colorectal and non-small-cell lung cancer | FDA cleared Phase III trial design (6/4) |
U.S. Bioscience and Alza Corp. | Ethyol | Amifostine; selective cytoprotective agent | Moderate to severe post-operative, radiation-induced xerostomia in patients undergoing radiation treatment for head and neck cancer | Oncologic Drugs Advisory Committee recommended approval(6/9); cleared for marketing (6/24) |
CENTRAL NERVOUS SYSTEM | ||||
Cypros Pharmaceutical Corp. | Ceresine | Small molecule; acts during and after ischemia by maintaining cellular ATP levels or accelerating their restoration | Severe brain injury | Granted orphan drug status (6/30) |
INFECTION | ||||
Gilead Sciences Inc. | | Adefovir dipivoxil; reverse transcriptase inhibitor (oral) | HIV-infected patients with disease progression despite prior reverse transcriptase inhibitor therapy | Submitted NDA (6/29) |
ID Biomedical Corp. (Canada) | | Group A streptococcus (GAS) vaccine; subunit vaccine made from recombinantly produced terminal fragments of the surface M protein | Preventive vaccine against group A streptococcus infection | IND cleared (6/9) |
Xoma Ltd. | rBPI-21 | Modified recombinant fragment of bactericidal/permeability-increasingprotein | Treatment of otitis media with effusion | Results of the Netherlands trial presented at the 7th International Symposium on Recent Advances in Otitis Media in Ft. Lauderdale, Fla. (6/2) |
MISCELLANEOUS | ||||
Alkermes Inc. and Genentech Inc. | Nutropin Depot | Sustained release formulation of Genentech's recombinant growth hormone based on Alkermes' ProLease injectable delivery system (administered once or twice a month) | Growth hormone deficiency in children | Submitted NDA (6/28) |
Alza Corp. | Ditropan XL (FDA-approved) | Oxybutynin chloride extended-release tablets (via OROS osmotic drug-delivery technology); tablet formulation | Overactive bladder | Agency cleared 15 mg tablets for marketing (alongside previously approved 5 mg and 10 mg formulations) (6/24) |
DUSA Pharmaceuticals Inc. (Canada; NASDAQ:DUSA) | Levulan | Photodynamic therapy; 20% solution of amino-levulinic acid HCl (topical) | Multiple actinic keratoses of the face and scalp | Received approvable letter (6/29) |
SangStat Medical Corp. | | Generic azathioprine; immuno-suppressant that inhibitis development of T-cells by interfering with the differentiation and proliferation of activated lymphocytes | Adjunct therapy for prevention of organ transplant rejection | Abbreviated NDA filed (6/14) |
