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New Drug Approvals Archive for 2004

See also: New Indications and Dosage Forms for 2004

Acetadote (acetylcysteine) Injection

Date of Approval: January 23, 2004
Company: Cumberland Pharmaceuticals
Treatment for: Acetaminophen Overdose

Acetadote (acetylcysteine) is an injectable treatment to prevent or lessen potential liver damage resulting from acetaminophen overdose.

Caduet (amlodipine and atorvastatin) Tablets

Date of Approval: January 30, 2004
Company: Pfizer Inc.
Treatment for: High Blood Pressure, Dyslipidemia, Angina

Caduet (amlodipine and atorvastatin) is calcium channel blocker and HMG-CoA reductase inhibitor combination used for the treatment of hypertension, angina and for the prevention of cardiovascular disease.

Spiriva (tiotropium bromide) Inhalation Powder

Date of Approval: January 30, 2004
Company: Boehringer Ingelheim
Treatment for: COPD, Maintenance

Spiriva HandiHaler (tiotropium bromide) is an anticholinergic indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations.

Alimta (pemetrexed) Injection

Date of Approval: February 4, 2004
Company: Eli Lilly
Treatment for: Malignant Pleural Mesothelioma, Non-Small Cell Lung Cancer

Alimta (pemetrexed) is an antifolate antineoplastic agent indicated for the treatment of malignant pleural mesothelioma and locally-advanced and metastatic non-small cell lung cancer (NSCLC).

Orthovisc (sodium hyaluronate) Injection

Date of Approval: February 4, 2004
Company: Anika Therapeutics, Inc.
Treatment for: Osteoarthritis

Orthovisc is a highly purified, high molecular weight form of hyaluronic acid used for treating pain in patients suffering from osteoarthritis (OA) of the knee who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics.

Fazaclo (clozapine) Orally Disintegrating Tablets

Date of Approval: February 9, 2004
Company: Alamo Pharmaceuticals
Treatment for: Schizophrenia

Fazaclo is an orally disintegrating atypical antipsychotic indicated for the treatment of schizophrenia.

EstroGel (estradiol topical) Gel

Date of Approval: February 9, 2004
Company: Solvay Pharmaceuticals
Treatment for: Postmenopausal Symptoms

EstroGel (estradiol) is transdermal gel estrogen therapy for the treatment of moderate to severe vasomotor symptoms, as well as vulvar and vaginal atrophy associated with the menopause.

Rhophylac (Rh0(D) immune globulin intravenous (human)) Injection

Date of Approval: February 12, 2004
Company: ZLB Bioplasma AG, Switzerland
Treatment for: Prevention of Rho(D) Sensitization

Rhophylac (Rh0(D) immune globulin intravenous (human)) is indicated for the suppression of rhesus (Rh) isoimmunization in pregnancy, obstetric conditions and incompatible transfusions, and the treatment of immune thrombocytopenic purpura.

Erbitux (cetuximab) Injection

Date of Approval: February 12, 2004
Company: Eli Lilly and Company
Treatment for: Colorectal Cancer, Head and Neck Cancer

Erbitux is epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of:
  • Head and Neck Cancer
    • Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy.
    • Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinumbased therapy with fluorouracil.
    • Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy.
  • Colorectal Cancer
    K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test
    • in combination with FOLFIRI for first-line treatment,
    • in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy,
    • as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.

Avastin (bevacizumab) Injection

Date of Approval: February 26, 2004
Company: Genentech, Inc.
Treatment for: Colorectal Cancer, Non-Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Hepatocellular Carcinoma

Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody for the treatment of colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer, fallopian tube cancer, peritoneal cancer, and hepatocellular carcinoma.

Myfortic (mycophenolic acid) Tablets

Date of Approval: February 27, 2004
Company: Novartis Pharma AG
Treatment for: Organ Transplant, Rejection Prophylaxis

Myfortic is an enteric-coated formulation of mycophenolic acid for use in combination with cyclosporine and corticosteroids to prevent organ rejection in kidney transplant patients.

Iquix (levofloxacin ophthalmic) Ophthalmic Solution

Date of Approval: March 1, 2004
Company: Santen
Treatment for: Corneal Ulcer

Marketing Status: Discontinued

Iquix (levofloxacin) is a topical fluoroquinolone indicated for the treatment of bacterial corneal ulcers.

Sensipar (cinacalcet) Tablets

Date of Approval: March 8, 2004
Company: Amgen Inc.
Treatment for: Secondary Hyperparathyroidism, Hypercalcemia of Malignancy

Sensipar (cinacalcet) is a calcimimetic agent indicated for the treatment of secondary hyperparathyroidism in dialysis patients and for the treatment of hypercalcemia in patients with parathyroid carcinoma.

Follistim AQ (follitropin beta) Injection

Date of Approval: March 24, 2004
Company: Organon USA Inc.
Treatment for: Female Infertility, Hypogonadism, Male, Ovulation Induction

Follistim AQ (follitropin beta) is human follicle-stimulating hormone prescribed for women undergoing assisted reproductive treatments (ART) such as in vitro fertilization (IVF), and for the induction of ovulation to achieve pregnancy, and for men with hypogonadism.

Ribasphere (ribavirin) Capsules

Date of Approval: April 6, 2004
Company: Three Rivers Pharmaceuticals, LLC
Treatment for: Hepatitis C

Ribasphere (ribavirin) is a nucleoside analogue indicated in combination with peginterferon alfa-2a for the treatment of adults with chronic hepatitis C virus infection.

ChiRhoStim (secretin synthetic human) - formerly Human Secretin

Date of Approval: April 9, 2004
Company: ChiRhoClin, Inc.
Treatment for: Diagnosis and Investigation

ChiRhoStim is indicated for use in diagnostic procedures.

Apidra (insulin glulisine) Injection

Date of Approval: April 16, 2004
Company: Aventis Pharmaceuticals Inc.
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Apidra (insulin glulisine) is a rapid-acting recombinant DNA human insulin analogue used for the control of hyperglycemia in patients with diabetes mellitus.

Apokyn (apomorphine) Injection

Date of Approval: April 20, 2004
Company: Bertek Pharmaceuticals
Treatment for: Parkinson's Disease

Apokyn (apomorphine) is a non-ergoline dopamine agonist indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinson’s disease.

Fortamet (metformin) Extended-Release Tablets

Date of Approval: April 28, 2004
Company: Andrx Corporation
Treatment for: Diabetes, Type 2

Marketing Status: Discontinued.

Fortamet (metformin) is an extended-release antihyperglycemic for the treatment of type 2 diabetes.

Vitrase (hyaluronidase) for Injection

Date of Approval: May 5, 2004
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Hypodermoclysis, Subcutaneous Urography

Vitrase is a preparation of purified ovine testicular hyaluronidase indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

HalfLytely and Bisacodyl Tablets (bisacodyl and polyethylene glycol (PEG) 3350 with electrolytes) Bowel Prep Kit

Date of Approval: May 10, 2004
Company: Braintree Laboratories, Inc.
Treatment for: Bowel Preparation

Marketing Status: Discontinued

HalfLytely and Bisacodyl Tablet Bowel Prep Kit is a combination of PEG-3350, an osmotic laxative and bisacodyl, a stimulant laxative, indicated for cleansing of the colon as a preparation for colonoscopy in adults.

LidoSite (lidocaine and Epinephrine) Topical System

Date of Approval: May 10, 2004
Company: Vyteris, Inc.
Treatment for: Local Anesthesia

LidoSite (lidocaine and epinephrine) is an iontophoretic delivery system providing local analgesia prior to the administration of superficial dermatological procedures.

Enjuvia (synthetic conjugated estrogens, B) Tablets

Date of Approval: May 10, 2004
Company: Duramed Pharmaceuticals
Treatment for: Postmenopausal Symptoms, Atrophic Vaginitis

Marketing Status: Discontinued

Enjuvia (synthetic conjugated estrogens, B) is a synthetic conjugated estrogen product indicated for the treatment of menopausal vasomotor symptoms and for the treatment of vaginal dryness and atrophy.

Tindamax (tinidazole) Tablets

Date of Approval: May 17, 2004
Company: Presutti Laboratories
Treatment for: Trichomoniasis, Giardiasis, Bacterial Vaginosis

Tindamax (tinidazole) is a synthetic nitroimidazole antiprotozoal agent for the treatment of trichomoniasis, giardiasis, amebiasis, and bacterial vaginosis in nonpregnant women.

DepoDur (morphine sulfate) extended-release liposome Injection

Date of Approval: May 18, 2004
Company: SkyePharma PLC and Endo Pharmaceuticals
Treatment for: Pain

Marketing Status: Discontinued

DepoDur (morphine sulfate extended-release liposome injection) is an opiate for the treatment of pain following major surgery.

Vidaza (azacitidine) for Injectable Suspension

Date of Approval: May 19, 2004
Company: Pharmion Corporation
Treatment for: Myelodysplastic Diseases

Vidaza (azacitidine) is an antineoplastic agent for the treatment of patients with myelodysplastic syndromes.

Octagam (immune globulin intravenous (human)) Injection

Date of Approval: May 21, 2004
Company: Octapharma AG
Treatment for: Primary Immunodeficiency Syndrome, Idiopathic Thrombocytopenic Purpura, Dermatomyositis

Octagam (immune globulin intravenous (human)) is a ready-to-use immunoglobulin intravenous (IGIV) product indicated for the treatment of primary humoral immunodeficiency, chronic immune thrombocytopenic purpura (ITP) and dermatomyositis.

Xifaxan (rifaximin) Tablets

Date of Approval: May 25, 2004
Company: Salix Pharmaceuticals, Ltd
Treatment for: Traveler's Diarrhea, Hepatic Encephalopathy, Irritable Bowel Syndrome

Xifaxan (rifaximin) is a nonsystemic antibiotic indicated for the treatment of patients with traveler's diarrhea caused by noninvasive strains of Escherichia coli, to reduce the risk of recurrence of hepatic encephalopathy in patients with advanced liver disease, and for the treatment of irritable bowel syndrome with diarrhea (IBS-D).

Sanctura (trospium chloride) Tablets

Date of Approval: May 28, 2004
Company: Allergan, Inc.
Treatment for: Urinary Frequency, Urinary Incontinence, Overactive Bladder

Marketing Status: Discontinued

Sanctura (trospium chloride) is an antispasmodic, antimuscarinic agent indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Istalol (timolol maleate ophthalmic) Solution

Date of Approval: June 4, 2004
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Glaucoma

Istalol (timolol maleate ophthalmic solution) is a beta-blocking agent for the treatment of glaucoma.

Menostar (estradiol transdermal system)

Date of Approval: June 8, 2004
Company: Berlex
Treatment for: Prevention of Osteoporosis

Menostar (estradiol transdermal system) is an estrogen patch for the prevention of postmenopausal osteoporosis.

Zegerid (omeprazole and sodium bicarbonate) - formerly Rapinex

Date of Approval: June 15, 2004
Company: Santarus, Inc.
Treatment for: Duodenal Ulcer, GERD, Stomach Ulcer, Erosive Esophagitis

Zegerid (omeprazole and sodium bicarbonate) is proton-pump inhibitor and antacid combination for the treatment of duodenal ulcer, heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), and erosive esophagitis.

Codeprex (chlorpheniramine polistirex and codeine polistirex) Extended Release Suspension

Date of Approval: June 21, 2004
Company: Lannett Company, Inc.
Treatment for: Cough

Marketing Status: Discontinued

Codeprex (chlorpheniramine polistirex and codeine polistirex) is an antihistamine and cough suppressant combination for the treatment of cough.

Mucinex D (guaifenesin and pseudoephedrine) Extended-Release Tablets

Date of Approval: June 22, 2004
Company: Adams Respiratory Therapeutics
Treatment for: Cough and Nasal Congestion

Mucinex D (guaifenesin and pseudoephedrine) is an expectorant and decongestant combination used for the relief of coughs and congestion associated with colds and allergies.

Alinia (nitazoxanide) Tablets

Date of Approval: July 21, 2004
Company: Romark Laboratories
Treatment for: Traveler's Diarrhea

Alinia (nitazoxanide) is an antiprotozoal agent indicated for the treatment of diarrhea caused by Giardia lamblia in patients 12 years of age and older.

Vytorin (ezetimibe/simvastatin) Tablets

Date of Approval: July 23, 2004
Company: Merck/Schering-Plough Pharmaceuticals
Treatment for: High Cholesterol, Familial Heterozygous, High Cholesterol, Familial Homozygous

Vytorin (ezetimibe/simvastatin) is a combination of ezetimibe (a lipid-lowering compound) and simvastatin (an HMG-CoA reductase inhibitor) for the treatment of high LDL cholesterol (LDL-C) in patients with primary hypercholesterolemia or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.

Metvixia (methyl aminolevulinate hydrochloride) Cream

Date of Approval: July 27, 2004
Company: PhotoCure ASA
Treatment for: Keratosis

Marketing Status: Discontinued

Metvixia (methyl aminolevulinate hydrochloride) is a porphyrin precursor used in combination with the Aktilite CL128 lamp for treatment of actinic keratoses.

Campral (acamprosate calcium) Delayed-Release Tablets

Date of Approval: July 29, 2004
Company: Allergan, Inc.
Treatment for: Alcohol Dependence

Marketing Status: Discontinued

Campral (acamprosate calcium) is a synthetic compound resembling the endogenous amino acid homotaurine indicated for treating alcohol dependence.

Epzicom (abacavir and lamivudine) Tablets

Date of Approval: August 2, 2004
Company: ViiV Healthcare
Treatment for: HIV Infection

Epzicom (abacavir and lamivudine) is a combination of two nucleoside reverse transcriptase inhibitors (NRTIs) indicated for use with other antiretroviral drugs for the treatment of HIV-1 infection in adults.

Truvada (emtricitabine and tenofovir) Tablets

Date of Approval: August 2, 2004
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection, Pre-Exposure Prophylaxis

Truvada (emtricitabine and tenofovir disoproxil fumarate) is a combination of nucleoside analog HIV-1 reverse transcriptase inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection, and for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in people at high risk.

Sculptra (injectable poly-L-lactic acid)

Date of Approval: August 3, 2004
Company: Sanofi-aventis U.S.
Treatment for: Facial Lipoatrophy; Facial Wrinkles

Sculptra (injectable poly-L-lactic acid) is a dermal filler indicated for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Sculptra Aesthetic is indicated for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles in healthy patients.

Cymbalta (duloxetine) Delayed-Release Capsules

Date of Approval: August 3, 2004
Company: Eli Lilly and Company
Treatment for: Neuropathic Pain, Pain, Osteoarthritis, Generalized Anxiety Disorder, Depression, Fibromyalgia, Diabetic Kidney Disease

Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) indicated for the treatment of major depressive disorder, neuropathic pain associated with diabetic peripheral neuropathy, generalized anxiety disorder, fibromyalgia and chronic musculoskeletal pain.

Femtrace (estradiol acetate) Tablets

Date of Approval: August 20, 2004
Company: Warner Chilcott
Treatment for: Postmenopausal Symptoms

Marketing Status: Discontinued

Femtrace (estradiol) is an oral estrogen indicated for the relief of postmenopausal vasomotor symptoms.

Fluxid (famotidine) Orally Disintegrating Tablets

Date of Approval: September 24, 2004
Company: Schwarz Pharma, Inc.
Treatment for: Duodenal Ulcer, Stomach Ulcer, GERD, Zollinger-Ellison Syndrome

Marketing Status: Discontinued

Fluxid (famotidine orally disintegrating tablets) is a histamine H2-receptor antagonist indicated for the treatment of ulcers, gastroesophageal reflux disease and pathological hypersecretory conditions.

Palladone (hydromorphone hydrochloride) Extended Release Capsules

Date of Approval: September 24, 2004
Company: Purdue Pharma L.P.
Treatment for: Pain

Marketing Status: Discontinued

Palladone (hydromorphone hydrochloride) is an extended release opioid analgesic indicated for the management of moderate to severe pain in patients requiring continuous, around-the-clock analgesia.

OraDisc A (amlexanox) Mucoadhesive Patch

Date of Approval: September 29, 2004
Company: Access Pharmaceuticals, Inc.
Treatment for: Aphthous Ulcer

OraDisc A is a mucoadhesive patch which gradually erodes and releases the active drug amlexanox when applied to the inside of the mouth. OraDisc A is approved for the treatment of aphthous ulcers in adults and adolescents 12 years of age and older with a normal immune system.

Luveris (lutropin alfa) for Injection

Date of Approval: October 8, 2004
Company: Serono, Inc.
Treatment for: Female Infertility

Marketing Status: Discontinued

Luveris (lutropin alfa) is a recombinant human form of luteinizing hormone indicated for use in combination with follitropin alfa for the stimulation of follicular development in infertile women.

Vantas (histrelin) Implant

Date of Approval: October 12, 2004
Company: Valera Pharmaceuticals
Treatment for: Prostate Cancer

Vantas (histrelin) implant is an LHRH agonist administered once-yearly for the palliative treatment of advanced prostate cancer.

Hylaform Plus (dermal filler)

Date of Approval: October 13, 2004
Company: Inamed Corporation and Genzyme Corporation
Treatment for: Wrinkle Correction

Hylaform Plus is a large particle size hyaluronic acid-based dermal filler that is indicated for the correction of moderate to severe facial wrinkles and folds.

Allegra-D 24 Hour (fexofenadine and pseudoephedrine)

Date of Approval: October 19, 2004
Company: Sanofi Aventis US
Treatment for: Allergic Rhinitis, Nasal Congestion

Allegra-D 24 Hour (fexofenadine and pseudoephedrine) is a once daily prescription antihistamine and decongestant formulation approved for the treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older.

Evoclin (clindamycin phosphate) Foam - formerly Actiza

Date of Approval: October 22, 2004
Company: Connetics Corporation
Treatment for: Acne

Evoclin (clindamycin) is a topical antibiotic indicated for the treatment of acne vulgaris.

Amphadase (hyaluronidase) Injection

Date of Approval: October 26, 2004
Company: Amphastar Pharmaceuticals, Inc
Treatment for: Adjuvant to increase the absorption and dispersion of other injected drugs

Amphadase (hyaluronidase) used as an adjunctive agent to facilitate the dispersion and absorption of other drugs.

Fosrenol (lanthanum carbonate) Chewable Tablets

Date of Approval: October 26, 2004
Company: Shire Pharmaceuticals Group plc
Treatment for: Hyperphosphatemia of Renal Failure

Fosrenol is a phosphate binder used to reduce high phosphorus levels in end-stage renal disease (ESRD) patients.

TriCor (fenofibrate) Tablets

Date of Approval: November 5, 2004
Company: Abbott Laboratories
Treatment for: Hyperlipoproteinemia Type IIa, Elevated LDL, Hyperlipoproteinemia Type IIb, Elevated LDL VLDL, Hyperlipoproteinemia, Hyperlipoproteinemia Type IV, Elevated VLDL, Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL, Hypertriglyceridemia

TriCor (fenofibrate tablets) is a lipid regulating agent indicated for the treatment of hypercholesterolemia and hypertriglyceridemia.

Omacor (omega-3-acid ethyl esters) Capsules

Date of Approval: November 10, 2004
Company: Reliant Pharmaceuticals, Inc.
Treatment for: Hypertriglyceridemia

Omacor (omega-3 polyunsaturated fatty acids) is indicated as an adjunct to diet for the reduction of triglycerides in adult patients with very high triglyceride levels.

Tarceva (erlotinib) Tablets

Date of Approval: November 18, 2004
Company: Genentech, Inc.
Treatment for: Non-Small Cell Lung Cancer, Pancreatic Cancer

Tarceva (erlotinib) is a kinase inhibitor indicated for:

  • the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) and for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.
  • first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.

VESIcare (solifenacin succinate) Tablets

Date of Approval: November 19, 2004
Company: Astellas Pharma Inc.
Treatment for: Overactive Bladder

VESIcare (solifenacin) is a muscarinic receptor antagonist for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
VESIcare LS is an oral suspension formulation of solifenacin for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 years and older.

Tysabri (natalizumab) Injection - formerly Antegren

Date of Approval: November 23, 2004
Company: Biogen Idec / Elan Corporation, plc
Treatment for: Multiple Sclerosis, Crohn's Disease, Maintenance

Tysabri (natalizumab) is a recombinant humanized IgG4κ monoclonal antibody for the treatment of multiple sclerosis and Crohn's disease.

Combunox (ibuprofen and oxycodone hydrochloride) Tablets

Date of Approval: November 26, 2004
Company: Forest Laboratories, Inc.
Treatment for: Pain

Marketing Status: Discontinued

Combunox (ibuprofen and oxycodone hydrochloride) is a nonsteroidal anti-inflammatory drug (NSAID) and opioid combination indicated for the short-term management of acute, moderate to severe pain.

Antara (fenofibrate) Capsules

Date of Approval: November 30, 2004
Company: Reliant Pharmaceuticals, Inc.
Treatment for: Hypertriglyceridemia, High Cholesterol, Familial Heterozygous

Antara (fenofibrate) is a lipid-lowering agent approved as adjunctive therapy to diet for the treatment of elevated levels of cholesterol and triglycerides.

Clindesse (clindamycin phosphate) Vaginal Cream

Date of Approval: November 30, 2004
Company: KV Pharmaceutical Company
Treatment for: Bacterial Vaginosis

Clindesse (clindamycin) Vaginal Cream is a single-dose topical antibiotic therapy indicated to treat bacterial vaginosis.

Captique (dermal filler) Injectable Gel

Date of Approval: November 12, 2004
Company: Inamed Corp / Genzyme Corp
Treatment for: Wrinkle Correction

Captique is a non-animal stabilized hyaluronic acid dermal filler indicated for the correction of moderate to severe facial wrinkles.

Equetro (carbamazepine) Extended-Release Capsules

Date of Approval: December 10, 2004
Company: Shire Pharmaceuticals Group plc
Treatment for: Bipolar Disorder

Equetro (carbamazepine) is an extended-release anticonvulsant indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder.

Zylet (loteprednol and tobramycin) Ophthalmic Suspension

Date of Approval: December 14, 2004
Company: Bausch & Lomb
Treatment for: Uveitis, Iritis, Conjunctivitis, Bacterial, Keratitis, Cyclitis

Zylet (loteprednol etabonate and tobramycin ophthalmic suspension) a topical anti-inflammatory corticosteroid and antibiotic combination for use in the treatment of inflammatory ocular conditions.

Lunesta (eszopiclone) Tablets - formerly Estorra

Date of Approval: December 15, 2004
Company: Sepracor Inc.
Treatment for: Insomnia

Lunesta (eszopiclone) is a nonbenzodiazepine hypnotic agent indicated for the treatment of patients who experience difficulty falling asleep as well as for the treatment of patients who are unable to sleep through the night (sleep maintenance difficulty).

Kepivance (palifermin) Injection

Date of Approval: December 15, 2004
Company: Amgen Inc.
Treatment for: Mucositis

Kepivance (palifermin) is a recombinant human keratinocyte growth factor indicated to decrease the incidence and duration of severe oral mucositis.

Macugen (pegaptanib) Ophthalmic Injection

Date of Approval: December 17, 2004
Company: Eyetech / Pfizer Inc
Treatment for: Macular Degeneration

Macugen (pegaptanib) is a selective vascular endothelial growth factor (VEGF) antagonist indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), an eye disease associated with aging that destroys central vision.

depo-subQ provera 104 (medroxyprogesterone acetate) Injection

Date of Approval: December 17, 2004
Company: Pfizer Inc.
Treatment for: Birth Control

depo-subQ provera 104 (medroxyprogesterone acetate) is a lower dose, subcutaneous formulation of Depo Provera indicated for the prevention of pregnancy in women of child bearing potential.

Enablex (darifenacin) Extended-Release Tablets

Date of Approval: December 22, 2004
Company: Allergan, Inc.
Treatment for: Overactive Bladder

Enablex (darifenacin) is a muscarinic receptor antagonist indicated for the treatment of overactive bladder.

Clolar (clofarabine) for Intravenous Infusion

Date of Approval: December 28, 2004
Company: Genzyme Corp.
Treatment for: Acute Lymphoblastic Leukemia

Clolar (clofarabine) is a purine nucleoside anti-metabolite indicated for the treatment of children with refractory or relapsed acute lymphoblastic leukemia (ALL).

Prialt (ziconotide) Intrathecal Infusion

Date of Approval: December 28, 2004
Company: Elan Corporation, plc
Treatment for: Pain

Prialt (ziconotide) is a non-opioid intrathecal (IT) therapy indicated for the management of severe chronic pain in patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.

Ventavis (iloprost) Inhalation Solution

Date of Approval: December 29, 2004
Company: CoTherix, Inc.
Treatment for: Pulmonary Hypertension

Ventavis (iloprost) inhalation solution is synthetic analogue of prostacyclin PGIB2B indicated for the treatment of pulmonary arterial hypertension.

Lyrica (pregabalin) Capsules

Date of Approval: December 30, 2004
Company: Pfizer Inc.
Treatment for: Neuropathic Pain, Postherpetic Neuralgia, Fibromyalgia, Diabetic Peripheral Neuropathy, Epilepsy

Lyrica (pregabalin) is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia and spinal cord injury; as an adjunctive therapy for partial onset seizures and for the treatment of fibromyalgia.

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