New Drug Approvals Archive for 2004

Acetadote (acetylcysteine) Injection

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

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

• Acetadote Cumberland Pharmaceuticals - Treatment for Acetaminophen Overdose
• Acetadote (acetylcysteine) FDA Approval History

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.

• Caduet High Blood Pressure and High Cholesterol - Treatment for High Blood Pressure and High Cholesterol
• Caduet (amlodipine and atorvastatin) FDA Approval History

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.

• Spiriva HandiHaler Boehringer Ingelheim - Treatment for Chronic Obstructive Pulmonary Disease (COPD)
• Spiriva (tiotropium bromide) FDA Approval History

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).

• FDA Approves Alimta for Malignant Pleural Mesothelioma
• Alimta (pemetrexed) FDA Approval History

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.

• Orthovisc Anika Therapeutics, Inc. - Treatment for Osteoarthritis of the Knee
• Orthovisc (sodium hyaluronate) FDA Approval History

Fazaclo (clozapine) Orally Disintegrating Tablets

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

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

• Fazaclo Alamo Pharmaceuticals - Treatment for Schizophrenia
• Fazaclo (clozapine) FDA Approval History

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.

• EstroGel Solvay Pharmaceuticals - Treatment for Menopausal Vasomotor Symptoms
• EstroGel (estradiol topical) FDA Approval History

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.

• Rhophylac ZLB Bioplasma AG, Switzerland - Treatment for Prevention of Rho(D) Sensitization
• Rhophylac (Rh0(D) immune globulin intravenous (human)) FDA Approval History

Erbitux (cetuximab) Injection

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

• 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.

• FDA Approves Erbitux (cetuximab) to Treat Irinotecan Refractory or Intolerant Metastatic Colorectal Cancer
• Erbitux (cetuximab) FDA Approval History

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.

• Avastin Approved for treatment for Metastatic Colorectal Cancer
• Avastin (bevacizumab) FDA Approval History

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.

• Myfortic Novartis Pharma AG - Treatment for Prevention of Organ Rejection
• Myfortic (mycophenolic acid) FDA Approval History

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.

• Iquix Santen - Treatment for Bacterial Corneal Ulcers
• Iquix (levofloxacin ophthalmic) FDA Approval History

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.

• Sensipar Amgen Inc. - Treatment for Secondary Hyperparathyroidism in dialysis patients
• Sensipar (cinacalcet) FDA Approval History

Follistim AQ (follitropin beta) Injection

Date of Approval: March 24, 2004
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.

• Follistim AQ Organon USA Inc. - Treatment for Infertility
• Follistim AQ (follitropin beta) FDA Approval History

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.

• Ribasphere Three Rivers Pharmaceuticals - Treatment for Hepatitis C ("HCV")
• Ribasphere (ribavirin) FDA Approval History

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.

• Human Secretin ChiRhoClin, Inc. - Treatment for Secretin Stimulation Testing
• ChiRhoStim (secretin synthetic human) FDA Approval History

Apidra (insulin glulisine) Injection

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

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

• Apidra Aventis Pharmaceuticals Inc. - Treatment for Diabetes Mellitus
• Apidra (insulin glulisine) FDA Approval History

Apokyn (apomorphine) Injection

Date of Approval: April 20, 2004
Company: Supernus Pharmaceuticals, Inc.
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.

• Apokyn Bertek Pharmaceuticals - Treatment for Parkinson’s Disease
• Apokyn (apomorphine) FDA Approval History

Fortamet (metformin) Extended-Release Tablets

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

Marketing Status: Discontinued.

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

• FDA Approves Fortamet (metformin HCl) Extended-Release Tablets for Type 2 Diabetes
• Fortamet (metformin) FDA Approval History

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.

• Vitrase ISTA Pharmaceuticals, Inc. - Treatment for Spreading Agent
• Vitrase (hyaluronidase) FDA Approval History

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.

• HalfLytely Braintree Laboratories, Inc. - Treatment for Colonoscopy Preparation
• HalfLytely and Bisacodyl Tablets (bisacodyl and polyethylene glycol (PEG) 3350 with electrolytes) FDA Approval History

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.

• LidoSite Vyteris, Inc. - Treatment for Localized Pain
• LidoSite (lidocaine and Epinephrine) FDA Approval History

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.

• Enjuvia Duramed Pharmaceuticals - Treatment for Menopausal Vasomotor Symptoms
• Enjuvia (synthetic conjugated estrogens, B) FDA Approval History

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.

• Tindamax Presutti Laboratories - Treatment for Infections
• Tindamax (tinidazole) FDA Approval History

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.

• DepoDur SkyePharma PLC and Endo Pharmaceuticals - Treatment for Post-Surgical Pain Relief
• DepoDur (morphine sulfate) FDA Approval History

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.

• FDA Approves Vidaza for Myelodysplastic Syndromes (MDS)
• Vidaza (azacitidine) FDA Approval History

Octagam (immune globulin intravenous (human)) Injection

Date of Approval: May 21, 2004
Company: Octapharma AG
Treatment for: Primary Immunodeficiency Syndrome, Immune Thrombocytopenia, 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.

• FDA Approves Octagam 5% for the for the Treatment of Primary Immunodeficiency Diseases
• Octagam (immune globulin intravenous (human)) FDA Approval History

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).

• Xifaxan Salix Pharmaceuticals, Ltd - Treatment for Travelers’ Diarrhea
• Xifaxan (rifaximin) FDA Approval History

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.

• Sanctura Indevus Pharmaceuticals, Inc. - Treatment for Overactive Bladder
• Sanctura (trospium chloride) FDA Approval History

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.

• Istalol ISTA Pharmaceuticals, Inc. - Treatment for Glaucoma
• Istalol (timolol maleate ophthalmic) FDA Approval History

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.

• Menostar Berlex - Treatment for Osteoporosis Prevention
• Menostar (estradiol transdermal system) FDA Approval History

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.

• Zegerid Santarus, Inc. - Treatment for Heartburn/GERD, Erosive Esophagitis, Duodenal Ulcers
• Zegerid (omeprazole and sodium bicarbonate) FDA Approval History

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.

• Codeprex Celltech Group plc - Treatment for Cough
• Codeprex (chlorpheniramine polistirex and codeine polistirex) FDA Approval History

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.

• Mucinex D Adams Respiratory Therapeutics - Treatment for Cough and Congestion
• Mucinex D (guaifenesin and pseudoephedrine) FDA Approval History

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.

• Alinia Romark Laboratories - Treatment for Diarrhea
• Alinia (nitazoxanide) FDA Approval History

Vytorin (ezetimibe/simvastatin) Tablets

Date of Approval: July 23, 2004
Company: Organon 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.

• Vytorin Merck/Schering-Plough Pharmaceuticals - Treatment for Cholesterol Reduction
• Vytorin (ezetimibe/simvastatin) FDA Approval History

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.

• FDA Approves Metvixia for Actinic Keratosis
• Metvixia (methyl aminolevulinate hydrochloride) FDA Approval History

Campral (acamprosate calcium) Delayed-Release Tablets

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

Marketing Status: Discontinued

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

• Campral Forest Laboratories, Inc. and Merck - Treatment for Alcoholism
• Campral (acamprosate calcium) FDA Approval History

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.

• Epzicom GlaxoSmithKline - Treatment for HIV Infection
• Epzicom (abacavir and lamivudine) FDA Approval History

Truvada (emtricitabine and tenofovir) Tablets

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

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.

• Truvada Gilead Sciences, Inc. - Treatment for HIV Infection
• Truvada (emtricitabine and tenofovir) FDA Approval History

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.

• Sculptra Dermik Laboratories - Treatment for Facial Lipoatrophy in HIV Patients
• Sculptra (injectable poly-L-lactic acid) FDA Approval History

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.

• FDA Approves Cymbalta for the Treatment of Depression
• Cymbalta (duloxetine) FDA Approval History

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.

• Femtrace Warner Chilcott - Treatment for Menopausal Vasomotor Symptoms
• Femtrace (estradiol acetate) FDA Approval History

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.

• Fluxid Schwarz Pharma, Inc. - Treatment for Ulcers and other Gastrointestinal Conditions
• Fluxid (famotidine) FDA Approval History

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.

• FDA Approves Palladone (hydromorphone HCl extended-release) Capsules (CII) For The Management Of Persistent, Moderate To Severe Pain
• Palladone (hydromorphone hydrochloride) FDA Approval History

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.

• OraDisc A Access Pharmaceuticals, Inc. - Treatment for Aphthous Ulcers
• OraDisc A (amlexanox) FDA Approval History

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.

• Luveris Serono, Inc. - Treatment for Infertility
• Luveris (lutropin alfa) FDA Approval History

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.

• Vantas Valera Pharmaceuticals - Treatment for Prostate Cancer
• Vantas (histrelin) FDA Approval History

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.

• Hylaform Plus Inamed Corporation and Genzyme Corporation - Treatment for Wrinkle Correction
• Hylaform Plus (dermal filler) FDA Approval History

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.

• Allegra-D 24 Hour Aventis Pharmaceuticals Inc. - Treatment for Seasonal Allergy Symptoms with Nasal Congestion
• Allegra-D 24 Hour (fexofenadine and pseudoephedrine) FDA Approval History

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.

• Evoclin Connetics Corporation - Treatment for Acne
• Evoclin (clindamycin phosphate) FDA Approval History

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.

• Amphadase Amphastar Pharmaceuticals, Inc - Treatment for Adjunctive Agent
• Amphadase (hyaluronidase) FDA Approval History

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.

• Fosrenol Shire Pharmaceuticals Group plc - Treatment for Hyperphosphataemia in ESRD Patients
• Fosrenol (lanthanum carbonate) FDA Approval History

TriCor (fenofibrate) Tablets

Date of Approval: November 5, 2004
Company: AbbVie Inc.
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.

• TriCor Abbott Laboratories - Treatment for Lipid Disorders
• TriCor (fenofibrate) FDA Approval History

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.

• Omacor Reliant Pharmaceuticals, Inc. - Treatment for Hypertriglyceridemia
• Omacor (omega-3-acid ethyl esters) FDA Approval History

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 for the treatment of certain types of non-small cell lung cancer, and pancreatic cancer.

• FDA Approves Tarceva (erlotinib) for Non-Small Cell Lung Cancer (NSCLC)
• Tarceva (erlotinib) FDA Approval History

VESIcare (solifenacin succinate) Tablets

Date of Approval: November 19, 2004
Company: Astellas Pharma US, 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.

• FDA Approves Vesicare (solifenacin succinate) for the Treatment of Overactive Bladder
• VESIcare (solifenacin succinate) FDA Approval History

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.

• Tysabri Approved for Multiple Sclerosis
• Tysabri (natalizumab) FDA Approval History

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.

• Combunox Forest Laboratories, Inc. - Treatment for Moderate to Severe Pain
• Combunox (ibuprofen and oxycodone hydrochloride) FDA Approval History

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.

• Antara Reliant Pharmaceuticals, Inc. - Treatment for Hypercholesterolemia and Hypertriglyceridemia
• Antara (fenofibrate) FDA Approval History

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.

• Clindesse KV Pharmaceutical Company - Treatment for Bacterial Vaginosis
• Clindesse (clindamycin phosphate) FDA Approval History

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.

• Captique Inamed Corp / Genzyme Corp - Treatment for Facial Wrinkle Correction
• Captique (dermal filler) FDA Approval History

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.

• Equetro Shire Pharmaceuticals Group plc - Treatment for Bipolar Disorder
• Equetro (carbamazepine) FDA Approval History

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.

• Zylet Bausch & Lomb - Treatment for Inflammatory Ocular Conditions
• Zylet (loteprednol and tobramycin) FDA Approval History

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).

• Lunesta Sepracor Inc. - Treatment for Insomnia
• Lunesta (eszopiclone) FDA Approval History

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.

• Kepivance Amgen Inc. - Treatment for Severe Oral Mucositis in Cancer Patients
• Kepivance (palifermin) FDA Approval History

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.

• Macugen Eyetech / Pfizer Inc - Treatment for Neovascular (Wet) Age-Related Macular Degeneration
• Macugen (pegaptanib) FDA Approval History

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.

• depo-subQ provera 104 Pfizer Inc. - Treatment for Prevention of Pregnancy
• depo-subQ provera 104 (medroxyprogesterone acetate) FDA Approval History

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.

• Enablex Novartis Pharmaceuticals Corporation - Treatment for Overactive Bladder
• Enablex (darifenacin) FDA Approval History

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).

• Clolar Genzyme Corp. - Treatment for Leukemia in Children
• Clolar (clofarabine) FDA Approval History

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.

• Prialt Elan Corporation, plc - Treatment for Severe Chronic Pain
• Prialt (ziconotide) FDA Approval History

Ventavis (iloprost) Inhalation Solution

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

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

• Ventavis CoTherix, Inc. - Treatment for Pulmonary Arterial Hypertension
• Ventavis (iloprost) FDA Approval History

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.

• Lyrica Pfizer Inc. - Treatment for Neuropathic Pain
• Lyrica (pregabalin) FDA Approval History