New Drug Approvals Archive for 2003
See also: New Indications and Dosage Forms for 2003
Amevive (alefacept)
Date of Approval: January 30, 2003
Company: Biogen, Inc
Treatment for: Psoriasis
Amevive (alefacept) is a selective immunomodulating antipsoriatic agent used to treat moderate to severe chronic plaque psoriasis.
Cardizem LA (diltiazem hydrochloride) Extended-Release Tablets
Date of Approval: February 6, 2003
Company: Bausch Health US LLC
Treatment for: High Blood Pressure, Angina
Cardizem LA is an extended-release formulation of diltiazem for indicated for the once-daily treatment of hypertension and for the management of chronic stable angina.
Oxytrol (oxybutynin) Transdermal System
Date of Approval: February 26, 2003
Company: AbbVie Inc.
Treatment for: Overactive Bladder
Oxytrol (oxybutynin) is a transdermal therapy used to treat overactive bladder (OAB), with symptoms of urge urinary incontinence, urgency and frequency.
Fuzeon (enfuvirtide)
Date of Approval: March 13, 2003
Company: Roche
Treatment for: HIV Infection
Fuzeon (enfuvirtide) is a fusion inhibitor used in combination with other medicines to treat HIV infection.
Femring (estradiol acetate) Vaginal Ring
Date of Approval: March 20, 2003
Company: Galen Ltd
Treatment for: Postmenopausal Symptoms
Femring (estradiol acetate) is a vaginal estrogen product in the form of a flexible, self-inserted ring. Femring is indicated to treat both the hot flushes and vaginal symptoms associated with menopause.
Somavert (pegvisomant) for Injection
Date of Approval: March 25, 2003
Company: Pharmacia and Upjohn
Treatment for: Acromegaly
Somavert (pegvisomant) is a growth hormone receptor antagonist indicated for the treatment of acromegaly.
Emend (aprepitant) Capsules
Date of Approval: March 27, 2003
Company: Merck
Treatment for: Nausea/Vomiting, Chemotherapy Induced
Emend (aprepitant) is a substance P/neurokinin 1 (NK1) receptor antagonist used in combination with other antiemetic agents to prevent and control acute and delayed nausea and vomiting associated with chemotherapy.
Iprivask (desirudin) Injection
Date of Approval: April 4, 2003
Company: Aventis Pharmaceuticals, Inc
Treatment for: Deep Vein Thrombosis, Prophylaxis
Iprivask (desirudin) is a specific inhibitor of human thrombin indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing elective hip replacement surgery.
Factive (gemifloxacin) Tablets
Date of Approval: April 4, 2003
Company: LG Life Sciences, Ltd
Treatment for: Bacterial Infection
Factive (gemifloxacin) is a fluoroquinolone antibiotics indicated for the treatment of community-acquired pneumonia and acute bacterial exacerbation of chronic bronchitis.
Vigamox (moxifloxacin) Ophthalmic Solution
Date of Approval: April 15, 2003
Company: Alcon
Treatment for: Conjunctivitis, Bacterial
Vigamox (moxifloxacin) is a fourth generation fluoroquinilone antibiotic indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of bacteria.
Fabrazyme (agalsidase beta)
Date of Approval: April 24, 2003
Company: Genzyme Corp
Treatment for: Fabry Disease
Fabrazyme (agalsidase beta) is a recombinant form of human alpha-galactosidase A, administered intravenously for the treatment of Fabry Disease.
Aldurazyme (laronidase)
Date of Approval: April 30, 2003
Company: Biomarin Pharmaceutical
Treatment for: Mucopolysaccharidosis Type I
Aldurazyme (laronidase) is recombinant human alpha-L-iduronidaseis indicated for the treatment of mucopolysaccharidosis I (MPS I).
Iressa (gefitinib) Tablets
Date of Approval: May 5, 2003
Company: AstraZeneca
Treatment for: Non Small Cell Lung Cancer
Iressa (gefitinib) is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have specific epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Velcade (bortezomib) for Injection
Date of Approval: May 13, 2003
Company: Millennium Pharmaceuticals
Treatment for: Multiple Myeloma
Velcade is an antineoplastic agent indicated for the treatment of multiple myeloma and mantle cell lymphoma.
Uroxatral (alfuzosin) Extended-Release Tablets
Date of Approval: June 12, 2003
Company: Sanofi Synthelabo
Treatment for: Benign Prostatic Hyperplasia
Uroxatral (alfuzosin) an alpha-1-adrenergic receptor antagonist, is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
FluMist (Influenza Virus Vaccine, Live, Intranasal) Nasal Spray
Date of Approval: June 17, 2003
Company: MedImmune Vaccines, Inc
Treatment for: Influenza Prophylaxis
FluMist (influenza virus vaccine, live, intranasal) is a nasally administered vaccine intended for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
Reyataz (atazanavir sulfate) Capsules
Date of Approval: June 20, 2003
Company: Bristol Myers Squibb
Treatment for: HIV Infection
Reyataz is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Xolair (omalizumab) Injection
Date of Approval: June 20, 2003
Company: Genentech, Inc.
Treatment for: Asthma, Maintenance, Chronic Rhinosinusitis With Nasal Polyps, Food Allergies, Urticaria
Xolair (omalizumab) is an anti-IgE monoclonal antibody for use in the treatment of asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria.
Bexxar (Tositumomab and Iodine I 131 Tositumomab)
Date of Approval: June 27, 2003
Company: Corixa Corporation
Treatment for: Non-Hodgkin's Lymphoma
Bexxar is a dual-action therapy that combines the tumor-targeting ability of a cytotoxic monoclonal antibody and the therapeutic potential of radiation. Bexxar is indicated for the treatment of Non-Hodgkin’s lymphoma.
Emtriva (emtricitabine) Capsules
Date of Approval: July 2, 2003
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection
Emtriva (emtricitabine) is a nucleoside reverse transcriptase inhibitor (NRTI) used with other anti-HIV medicines to treat people with HIV infection.
Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) Otic Suspension
Date of Approval: July 18, 2003
Company: Alcon Research, Ltd.
Treatment for: Acute Otitis Externa, Middle Ear Infections
Ciprodex (ciprofloxacin/dexamethasone) is an antibiotic / anti-inflammatory combination used for the treatment of acute otitis media and acute otitis externa.
Clobex (clobetasol propionate) Lotion
Date of Approval: July 24, 2003
Company: Galderma Laboratories
Treatment for: Atopic Dermatitis, Psoriasis
Clobex (clobetasol) is a topical corticosteroid used to treat steroid-responsive dermatoses including moderate-to-severe atopic dermatitis and moderate-to-severe psoriasis.
Advate (antihemophilic factor [recombinant])
Date of Approval: July 25, 2003
Company: Baxter Healthcare Corp
Treatment for: Hemophilia A
Advate (antihemophilic factor [recombinant]) is indicated for use in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes, and also indicated in the perioperative management of patients with hemophilia A.
Aloxi (palonosetron) Injection
Date of Approval: July 25, 2003
Company: Helsinn Healthcare
Treatment for: Nausea/Vomiting, Chemotherapy Induced
Aloxi (palonosetron) is a 5-HT3 receptor antagonist indicated for the prevention of nausea and vomiting associated with chemotherapy.
Zavesca (miglustat) Capsules
Date of Approval: July 31, 2003
Company: Actelion Pharmaceuticals
Treatment for: Gaucher Disease
Zavesca (miglustat) is a glucosylceramide synthase inhibitor indicated for the treatment of adult patients with mild to moderate type 1 Gaucher disease.
Crestor (rosuvastatin calcium) Tablets
Date of Approval: August 12, 2003
Company: AstraZeneca
Treatment for: High Cholesterol, Familial Heterozygous, High Cholesterol, Familial Homozygous, Hypertriglyceridemia, Dyslipidemia, Prevention of Cardiovascular Disease
Crestor is an HMG-CoA reductase inhibitor approved as an adjunct to diet for the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. Crestor is also indicated for the primary prevention of cardiovascular disease.
Levitra (vardenafil hydrochloride) Tablets
Date of Approval: August 19, 2003
Company: Bayer Corporation
Treatment for: Erectile Dysfunction
Levitra is a phosphodiesterase type 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
Gamunex (immune globulin intravenous (human)) Injection
Date of Approval: August 27, 2003
Company: Bayer Corporation
Treatment for: Primary Immunodeficiency Syndrome, Immune Thrombocytopenia, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Gamunex (immune globulin intravenous (human)) is indicated for the treatment of primary humoral immunodeficiency, idiopathic thrombocytopenic purpura and chronic inflammatory demyelinating polyneuropathy (CIDP).
Seasonale (ethinyl estradiol and levonorgestrel) Tablets
Date of Approval: September 5, 2003
Company: Barr Laboratories
Treatment for: Birth Control
Seasonale (ethinyl estradiol and levonorgestrel) is an extended-cycle oral contraceptive.
Riomet (metformin hydrochloride) Oral Solution
Date of Approval: September 11, 2003
Company: Ranbaxy Pharmaceuticals Inc.
Treatment for: Type 2 Diabetes
Riomet is an oral solution formulation of the antihyperglycemic drug metformin indicated for the treatment of type 2 diabetes.
Cubicin (daptomycin) Injection
Date of Approval: September 12, 2003
Company: Merck
Treatment for: Skin and Structure Infection, Bacteremia
Cubicin (daptomycin) is a lipopeptide antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) and staphylococcus aureus bloodstream infections (bacteremia).
Jantoven (warfarin sodium) Tablets
Date of Approval: October 2, 2003
Company: Upsher-Smith
Treatment for: Thromboembolic Stroke Prophylaxis
Jantoven (warfarin) is an anticoagulant used to prevent heart attacks, strokes, and blood clots in veins and arteries. Jantoven is therapeutically equivalent to Coumadin.
Radiogardase (prussian blue insoluble) Capsules
Date of Approval: October 2, 2003
Company: HEYL Chemisch-pharmazeutische Fabrik GmbH
Treatment for: Radiation Emergency
Radiogardase (prussian blue) is used to treat people who have been contaminated with radioactive cesium or thallium, or non-radioactive thallium.
Estrasorb (estradiol topical ) Emulsion
Date of Approval: October 9, 2003
Company: Novovax
Treatment for: Postmenopausal Symptoms
Estrasorb is a topical estradiol emulsion approved for short-term use to reduce moderate to severe vasomotor symptoms (commonly known as "hot flashes") in menopausal women.
Namenda (memantine hydrochloride)
Date of Approval: October 16, 2003
Company: AbbVie Inc.
Treatment for: Alzheimer's Disease
Namenda is a low to moderate affinity NMDA (N-methyl-D-aspartate) receptor antagonist indicated for treatment of moderate to severe dementia of the Alzheimer’s type.
Elestat (epinastine hydrochloride) Ophthalmic Solution, 0.05%
Date of Approval: October 16, 2003
Company: Allergan, Inc.
Treatment for: Conjunctivitis, Allergic
Elestat (epinastine) is topical H1-receptor antagonist used for the prevention of itching associated with allergic conjunctivitis.
Lexiva (fosamprenavir calcium)
Date of Approval: October 20, 2003
Company: ViiV Healthcare
Treatment for: HIV Infection
Lexiva (fosamprenavir) is a protease inhibitor (PI) for the treatment of HIV infection in adults in combination with other antiretroviral medications. Lexiva offers flexible dosing with no food or water restrictions.
Raptiva (efalizumab) Injection
Date of Approval: October 27, 2003
Company: Genentech Inc.
Treatment for: Psoriasis
Raptiva (efalizumab) is a monoclonal antibody indicated for the treatment of adult patients with chronic moderate to severe plaque psoriasis.
Climara Pro (estradiol and levonorgestrel ) Transdermal System
Date of Approval: November 21, 2003
Company: Berlex Laboratories
Treatment for: Postmenopausal Symptoms
Climara Pro (estradiol and levonorgestrel) is a transdermal combined hormone therapy for the relief of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.
Cialis (tadalafil) Tablets
Date of Approval: November 21, 2003
Company: Eli Lilly and Co.
Treatment for: Erectile Dysfunction, Benign Prostatic Hyperplasia
Cialis is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile dysfunction, and to treat the signs and symptoms of benign prostatic hyperplasia.
Zorbtive (somatropin) for Injection
Date of Approval: December 1, 2003
Company: Serono, Inc.
Treatment for: Short Bowel Syndrome
Zorbtive [somatropin (rDNA origin) for injection] is recombinant human growth hormone indicated for the treatment of Short Bowel Syndrome in patients receiving specialized nutritional support.
Ertaczo (sertaconazole topical) Cream
Date of Approval: December 11, 2003
Company: Mylan Pharmaceuticals Inc.
Treatment for: Tinea Pedis
Ertaczo (sertaconazole) is an imidazole derivative antifungal indicated for the treatment of tinea pedis.
Restylane (dermal filler) Injectable Gel
Date of Approval: December 12, 2003
Company: Medicis
Treatment for: Facial Wrinkles
Restylane is a dermal filler made of a biodegradable non-animal stabilized hyaluronic acid used for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, the lines between the nose and mouth.
Oraqix (lidocaine and prilocaine) Periodontal Gel
Date of Approval: December 19, 2003
Company: Dentsply Pharmaceutical
Treatment for: Periodontal Anesthesia
Oraqix is a non-injectable anesthetic for periodontal applications. The anesthetic is delivered to the treatment site without the use of a needle and anesthetizes the site within 30 seconds for a period of approximately 20 minutes.
Symbyax (fluoxetine and olanzapine) Capsules
Date of Approval: December 24, 2003
Company: Eli Lilly
Treatment for: Bipolar Disorder, Depression
Symbyax (fluoxetine/olanzapine) is a selective serotonin reuptake inhibitor and atypical antipsycotic combination indicated for the acute treatment of depressive episodes associated with bipolar I disorder and treatment resistant depression.
Clobex (clobetasol propionate) Lotion
Date of Approval: July 24, 2003
Company: Galderma Laboratories
Treatment for: Atopic Dermatitis, Psoriasis
Clobex (clobetasol) is a topical corticosteroid used to treat steroid-responsive dermatoses including moderate-to-severe atopic dermatitis and moderate-to-severe psoriasis.
Climara Pro (estradiol and levonorgestrel ) Transdermal System
Date of Approval: November 21, 2003
Company: Berlex Laboratories
Treatment for: Postmenopausal Symptoms
Climara Pro (estradiol and levonorgestrel) is a transdermal combined hormone therapy for the relief of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.
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