Note: Recombinant proteins and monoclonal antibodies are underlined. This list includes monoclonal antibodies and recombinant proteins developed by biotechnology companies and pharmaceutical companies, as well as small-molecule products developed by biotechnology companies, and other selected small-molecule or tissue-engineered products considered relevant to the biotechnology industry. Dates are the dates of announcement of product approvals.
| Product |
Description |
Company |
Indication |
Date |
|
| ADVATE |
Recombinant antihemophilic factor produced without any added human or animal plasma proteins and albumin |
Baxter Healthcare Corp. |
Hemophilia A |
July |
| ALDURAZYME® |
Laronidase; recombinant enzyme replacement |
BioMarin Pharmaceuticals Inc. and Genzyme |
Mucopolysaccharidosis-1 |
April |
| Aloxi |
Palonosetron HCl injection; 5-HT3 receptor antagonist |
MGI Pharma and Helsinn Healthcare |
Prevention of acute nausea and vomiting in chemotherapy patients |
July |
| AMEVIVE® |
Alefacept; recombinant, dimeric fusion protein; targets CD45RO+ T-cells |
Biogen |
Moderate to severe chronic plaque psoriasis |
January |
| BEXXAR® |
Tositumomab and I-131 tositumomab; monoclonal antibody targeting the CD20 antigen and radiolabeled version of the antibody |
Corixa Corp. and GlaxoSmithKline |
CD20-positive, follicular non-Hodgkin's lymphoma whose disease is refractory to Rituxan and has relapsed following chemotherapy |
June |
| Cialis® |
Tadalafil; oral PD55 inhibitor |
Lilly ICOS LLC (joint venture of Eli Lilly and Co. and ICOS Corp.) |
Erectile dysfunction |
November |
CosmoDerm™/
CosmoPlast™ |
Dermal fillers containing human-based collagen |
Advanced Tissue Sciences Inc. and Inamed Corp. |
Wrinkle injections |
March |
| Cubicin™ |
Daptomycin for injection |
Cubist Pharmaceuticals Inc and Chiron Corp. |
Bacterial infections |
September |
| Elestat™ |
Epinastine HCl ophthalmic solution0.05% |
Inspire Pharmaceuticals Inc., Allergan Inc (Inspire signed a co-promotion agreement following approval of the Allergan drug) and Boehringer Ingelheim |
Persistent itching associated with allergic conjunctivitis |
October |
| Emtriva™ |
Emtricitabine; once-daily nucleoside reverse transcriptase inhibitor (capsule) |
Gilead Sciences Inc. |
Treatment of HIV infection in adults as part of combination |
July |
| ESTRASORB™ |
Estradiol topical emulsion |
Novavax Inc. and King Pharmaceuticals Inc. |
Short-term use to reduce moderate to severe vasomotor symptoms ("hot flashes") in menopausal women |
October |
| Fabrazyme® |
Algasidase beta; recombinant enzyme replacement |
Genzyme |
Fabry's disease |
April |
| FACTIVE® |
Gemifloxacin mesylate |
GeneSoft Pharmaceuticals Inc. |
Mild to moderate community-acquired pneumonia and acute bacterial exacerbation of chronic bronchitis |
April |
| FluMist™ |
Nasally delivered influenza vaccine |
MedImmune Inc. |
Prevention of flu |
June |
| FUZEON™ |
Enfuvirtide; fusion inhibitor (subcutaneous injection) |
Trimeris Inc. and Roche |
Component of combination therapy for HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy |
March |
| Ganite™ |
Gallium nitrate injection |
Genta Inc. |
Cancer-related hypercalcemia |
September |
| Lexiva™ |
Fosamprenavir calcium; protease inhibitor (tablet) |
Vertex Pharmaceuticals and GlaxoSmithKline |
Treatment of HIV infection in adults in combination with other antiretrovirals |
October |
| NAMENDA™ |
Memantine HCl; N-methyl-D-aspartate receptor antagonist (tablet) |
Neurobiological Technologies Inc. and Forest Laboratories |
Mild to moderate Alzheimer's |
October |
| Plenaxis™ |
Abarelix (injectable suspension); gonadotropin releasing hormone antagonist |
Praecis Pharmaceuticals Inc. |
Palliative treatment of men with advanced symptomatic prostate cancer under certain conditions |
November |
| RAPTIVA™ |
Efalizumab; selective, reversible T-cell blocker (subcutaneous injection; self-administered) |
Xoma Ltd. and Genentech Inc. |
Chronic moderate to severe plaque psoriasis in adults |
October |
RISPERDAL®
CONSTA™ |
Risperidone, long-acting injection formulation; uses Medisorb® drug delivery technology that encapsulates active medication in slow-degrading, polymer-based microspheres |
Alkermes Inc. and Johnson & Johnson |
Schizophrenia |
October |
| SOMAVERT® |
Pegvisomant; pegylated version of a recombinant human growth hormone analog structurally altered to act as a GH receptor antagonist |
Nektar Therapeutics and Pfizer Inc. |
Acromegaly |
March |
| VELCADE™ |
Bortezomib for injection; proteasome inhibitor |
Millennium Pharmaceuticals Inc. |
Relapsed and refractory multiple myeloma |
May |
| Xolair® |
Omalizumab; recombinant DNA-derived humanized monoclonal antibody targeting immunoglobin-E (subcutaneous) |
Genentech, Tanox Inc. and Novartis Pharmaceuticals |
Moderate to severe persistent asthma in adults and adolescents |
June |
| Zavesca™ |
Miglustat; substrate reduction therapy (capsule) |
Celltech Group plc and Actelion Ltd. |
Mild to moderate Gaucher's Disease patients for whom enzyme replacement therapy is not an option |
August |
| Product |
Description |
Company |
Indication |
Date |
|
| AVONEX® |
Interferon beta-1a; recombinant |
Biogen |
Treatment after initial multiple sclerosis attack if a brain MRI scan shows abnormalities characteristic of the disease |
February |
| Betaseron® |
Interferon beta-1b; recombinant |
Chiron and Berlex Laboratories Inc. |
New labeling includes data from studies in patients with secondary progressive multiple sclerosis, and the indications section reflects Betaseron is indicated for treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations |
March |
| ENBREL® |
Etanercept; recombinant product; dimeric fusion protein consisting of tumor necrosis factor receptor linked to the Fc portion of human IgG1 |
Amgen and Wyeth |
Ankylosing spondylitis; improvement of physical function in patients with moderately to severely active rheumatoid arthritis; expanded psoriatic arthritis label claiming blockage of progression |
July
July
Aug |
| FACTIVE® |
Gemifloxacin mesylate |
GeneSoft Pharmaceuticals Inc. |
Community-acquired pneumonia due to multi-drug resistant Streptococcus pneumoniae |
July |
GLIADEL®
Wafer |
Polifeprosan 20 with carmustine implant |
Guilford Pharmaceuticals Inc. |
Newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation |
February |
| Humatrope® |
Somatropin; recombinant |
Eli Lilly and Company |
Long-term treatment of children of short stature (unknown cause) |
July |
PHOTOFRIN®
PhotoDynamic Therapy |
Porfimer sodium; photodynamic therapy |
Axcan Pharma Inc |
Ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy |
August |
| REMICADE® |
Infliximab; recombinantly produced, chimeric monoclonal antibody |
Centocor Inc. |
Reduction of draining enterocutaneous and recto-vaginal fistulas and for maintaining fistula closure in patients with fistulizing Crohn's disease |
April |
| Synagis® |
Palivizumab; recombinantly produced, humanized monoclonal antibody |
MedImmune Inc. |
FDA cleared addition of new safety and efficacy data supporting the drug's use in young children with hemodynamically significant congenital heart disease |
September |
Zorbtive™
(Serostim®) |
Somatropin; recombinant |
Serono |
Short bowel syndrome (product previously approved under the trade name Serostim® for AIDS wasting) |
December |
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