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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: Biovail Laboratories Incorporated
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: Allergan, 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)

Date of Approval: June 17, 2003
Company: MedImmune Vaccines, Inc
Treatment for: Influenza Prophylaxis

FluMist is a live trivalent nasally administered vaccine intended for active immunization for the prevention of influenza.

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) Subcutaneous Injection

Date of Approval: June 20, 2003
Company: Genentech, Inc.
Treatment for: Asthma, Maintenance, Urticaria, Nasal Polyps

Xolair (omalizumab) is an anti-IgE monoclonal antibody indicated for:
  • moderate to severe persistent asthma in patients 6 years of age and older
  • chronic idiopathic urticaria in adults and adolescents 12 years of age and older
  • nasal polyps in adult patients 18 years of age and older.

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, Otitis Media

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, Idiopathic Thrombocytopenic Purpura, 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: Diabetes, Type 2

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: Cubist Pharmaceuticals
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: Allergan, 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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