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New Drug Approvals Archive for 2005

See also: New Indications and Dosage Forms for 2005

Abraxane (paclitaxel protein-bound) for Injectable Suspension

Date of Approval: January 7, 2005
Company: American Pharmaceutical Partners, Inc. / American Bioscience, Inc.
Treatment for: Breast Cancer, Non Small Cell Lung Cancer, Pancreatic Cancer

Abraxane (paclitaxel protein-bound) is an albumin-bound form of the antineoplastic agent paclitaxel indicated for the treatment of breast cancer, non-small cell lung cancer, and pancreatic cancer.

ThyroShield (potassium iodide) Oral Solution

Date of Approval: January 12, 2005
Company: Fleming & Company
Treatment for: Radiation Emergency

ThyroShield (potassium iodide) is used to protect the thyroid gland from the effects of radiation from inhaled or swallowed radioactive iodine.

Menactra (meningococcal conjugate vaccine)

Date of Approval: January 14, 2005
Company: Sanofi Pasteur
Treatment for: Meningococcal Disease Prophylaxis

Menactra (meningococcal conjugate vaccine) is a quadrivalent conjugate vaccine indicated for the prevention of meningococcal disease.

Niravam (alprazolam) Orally Disintegrating Tablets

Date of Approval: January 19, 2005
Treatment for: Anxiety, Panic Disorder

Marketing Status: Discontinued

Niravam (alprazolam) is an orally disintegrating benzodiazepine indicated for the short-term relief of anxiety and panic attacks.

Vanos (fluocinonide) Cream

Date of Approval: February 11, 2005
Company: Medicis
Treatment for: Psoriasis, Atopic Dermatitis, Dermatitis

Vanos (fluocinonide) is a corticosteroid (steroid hormone) approved to relieve the inflammation and itching caused by certain skin conditions that respond to treatment with corticosteroids in patients 12 years of age or older.

Ammonul (sodium benzoate and sodium phenylacetate) Injection

Date of Approval: February 17, 2005
Company: Medicis
Treatment for: Hyperammonemia

Ammonul (sodium benzoate and sodium phenylacetate) is indicated as an adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle.

Vaccinia (vaccinia immune globulin intravenous (human)) Injection

Date of Approval: May 2, 2005
Company: DynPort Vaccine Company LLC
Treatment for: Smallpox Vaccine Reaction

Vaccinia Immune Globulin Intravenous (Human) (VIGIV) indicated for the treatment of complications from smallpox vaccination

Clarinex-D 24 Hour (desloratadine and pseudoephedrine sulfate) ER Tablets

Date of Approval: March 3, 2005
Company: Schering-Plough Corporation
Treatment for: Allergic Rhinitis

Clarinex-D 24 Hour (desloratadine and pseudoephedrine sulfate) is a once-daily antihistamine and decongestant for the relief of the symptoms of seasonal allergic rhinitis.

Mycamine (micafungin sodium) for Injection

Date of Approval: March 16, 2005
Company: Astellas Pharma Inc.
Treatment for: Esophageal Candidiasis, Fungal Infection Prophylaxis, Candidemia

Mycamine (micafungin sodium) is an echinocandin antifungal agent indicated for the treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses, esophageal candidiasis, and for the prevention of candida Infections in patients undergoing Hematopoietic Stem Cell Transplantation (HSCT).

Symlin (pramlintide acetate) Injection

Date of Approval: March 16, 2005
Company: Amylin Pharmaceuticals, Inc.
Treatment for: Diabetes, Type 1, Type 2 Diabetes

Symlin (pramlintide acetate) is an antihyperglycemic drug for use in patients with diabetes treated with insulin.

Xibrom (bromfenac) Ophthalmic Solution

Date of Approval: March 24, 2005
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation

Marketing Status: Discontinued

Xibrom (bromfenac) is an ophthalmic nonsteroidal antiinflammatory drug (NSAID) for the treatment of postoperative pain and inflammation in patients who have undergone cataract extraction.

Baraclude (entecavir) Tablets / Oral Solution

Date of Approval: March 29, 2005
Company: Bristol-Myers Squibb Company
Treatment for: Hepatitis B

Baraclude (entecavir) is a nucleoside analogue oral antiviral therapy for the treatment of chronic hepatitis B in adults.

Asmanex (mometasone furoate) Inhalation Powder

Date of Approval: March 30, 2005
Company: Organon Pharmaceuticals
Treatment for: Asthma

Asmanex Twisthaler (mometasone furoate) is an inhaled corticosteroid for the treatment of asthma.

Fosamax Plus D (alendronate and cholecalciferol) Tablets

Date of Approval: April 7, 2005
Company: Organon Pharmaceuticals
Treatment for: Osteoporosis

Fosamax Plus D is a single once-weekly tablet containing the bisphosphonate drug alendronate, and seven days’ worth of vitamin D, an essential nutrient required for calcium absorption. Fosamax Plus D is used to reduce the risk of hip and spinal fractures in postmenopausal women with osteoporosis, and to increase bone mass in men with osteoporosis.

Retisert (fluocinolone acetonide) Intravitreal Implant

Date of Approval: April 8, 2005
Company: Bausch & Lomb
Treatment for: Uveitis

Retisert (fluocinolone acetonide) intravitreal implant is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

Byetta (exenatide) Injection

Date of Approval: April 28, 2005
Company: Amylin Pharmaceuticals / Eli Lilly & Co.
Treatment for: Type 2 Diabetes

Byetta (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Gammagard Liquid (immune globulin infusion (human)) Solution

Date of Approval: April 27, 2005
Company: Takeda Pharmaceuticals U.S.A., Inc.
Treatment for: Primary Immunodeficiency Syndrome, Multifocal Motor Neuropathy, Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Gammagard Liquid (immune globulin infusion (human)) is an immune globulin therapy for use in the treatment of primary humoral immunodeficiency, multifocal motor neuropathy, and chronic inflammatory demyelinating polyneuropathy.

Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap)) Injection

Date of Approval: May 3, 2005
Company: GlaxoSmithKline Biologicals
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis

Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed; Tdap) is a combination vaccine that provides immunization against pertussis (whooping cough) in combination with tetanus and diphtheria.

Triglide (fenofibrate) Tablets

Date of Approval: May 7, 2005
Company: SkyePharma PLC
Treatment for: Hyperlipoproteinemia, Hyperlipoproteinemia Type IIa, Elevated LDL, Hyperlipoproteinemia Type IIb, Elevated LDL VLDL, Hyperlipoproteinemia Type IV, Elevated VLDL, Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL, Hypertriglyceridemia

Triglide (fenofibrate) is a lipid-regulating agent for the treatment of hypercholesterolemia and hypertriglyceridemia.

Proquin XR (ciprofloxacin) Extended-Release Tablets

Date of Approval: May 19, 2005
Company: Depomed, Inc.
Treatment for: Urinary Tract Infection

Marketing Status: Discontinued

Proquin XR (ciprofloxacin) is an extended release fluoroquinolone antibiotic indicated for the treatment of urinary tract infections.

Focalin XR (dexmethylphenidate) Extended-Release Capsules

Date of Approval: May 26, 2005
Company: Novartis Pharmaceuticals Corporation
Treatment for: ADHD

Focalin XR (dexmethylphenidate) is a once-daily extended-release form of Focalin indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and children.

Naglazyme (galsulfase) - formerly Aryplase

Date of Approval: May 31, 2005
Company: BioMarin Pharmaceutical Inc.
Treatment for: Mucopolysaccharidosis Type VI

Naglazyme (galsulfase) is an enzyme-replacement therapy for treatment of mucopolysaccharidosis VI (MPS VI), an inherited, life-threatening lysosomal storage disorder caused by a deficiency of the lysosomal enzyme N-acetylgalactosamine 4-sulfatase (also known as arylsulfatase B).

Revatio (sildenafil citrate)

Date of Approval: June 3, 2005
Company: Pfizer Inc.
Treatment for: Pulmonary Arterial Hypertension

Revatio (sildenafil) is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension.

Glumetza (metformin extended release) Tablets

Date of Approval: June 3, 2005
Company: Biovail Corporation/Depomed, Inc.
Treatment for: Type 2 Diabetes

Glumetza (metformin extended-release) is a once-daily oral antihyperglycemic formulation indicated for the treatment of type 2 diabetes.

Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap))

Date of Approval: June 10, 2005
Company: Aventis Pasteur Limited
Treatment for: Tetanus Prophylaxis, Diphtheria Prophylaxis, Pertussis Prophylaxis

Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)) is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis.

Tygacil (tigecycline) Injection

Date of Approval: June 15, 2005
Company: Wyeth Pharmaceuticals
Treatment for: Skin and Structure Infection, Intraabdominal Infection, Pneumonia

Tygacil (tigecycline) is a glycylcycline antibacterial indicated for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections and community-acquired bacterial pneumonia in adults.

Levemir (insulin detemir) Injection

Date of Approval: June 16, 2005
Company: Novo Nordisk Inc.
Treatment for: Diabetes, Type 1, Type 2 Diabetes

Levemir (insulin detemir) is a novel, long- acting form of insulin that provides up to a 24-hour duration of action for the treatment of diabetes mellitus (type 1 and type 2).

Aptivus (tipranavir) Capsules

Date of Approval: June 22, 2005
Company: Boehringer Ingelheim
Treatment for: HIV Infection

Aptivus (tipranavir) is a non-peptidic protease inhibitor which is co-administered with ritonavir for the treatment of HIV Infection.

Synera (lidocaine and tetracaine) Topical Patch - formerly S-Caine Patch

Date of Approval: June 23, 2005
Company: ZARS, Inc.
Treatment for: Local Anesthesia

Synera (lidocaine and tetracaine) is a local anesthetic patch indicated for use on intact skin to provide local dermal analgesia before certain medical procedures

BiDil (isosorbide dinitrate and hydralazine) Tablets

Date of Approval: June 23, 2005
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Heart Failure

BiDil is a fixed-dose combination of isosorbide dinitrate (a vasodilator) and hydralazine hydrochloride (an arterial dilator) indicated for the treatment of heart failure in black patients.

Rozerem (ramelteon) Tablets

Date of Approval: July 22, 2005
Company: Takeda Pharmaceuticals North America, Inc.
Treatment for: Insomnia

Rozerem (ramelteon) is an orally active hypnotic indicated for the treatment of insomnia characterized by difficulty with sleep onset.

Fortical (calcitonin) Nasal Spray

Date of Approval: August 12, 2005
Company: Unigene / Upsher-Smith Laboratories, Inc.
Treatment for: Osteoporosis

Marketing Status: Discontinued

Fortical is a nasal calcitonin formulation indicated for the treatment of postmenopausal osteoporosis.

Actonel with Calcium (risedronate sodium and calcium carbonate)

Date of Approval: August 12, 2005
Company: Procter & Gamble Pharmaceuticals, Inc.
Treatment for: Osteoporosis

Marketing Status: Discontinued

Actonel with Calcium (risedronate sodium and calcium carbonate) is a conveniently packaged combination of Actonel tablets (a bisphosphonate) and calcium tablets. Actonel with Calcium is a prescription therapy indicated for the prevention and treatment of postmenopausal osteoporosis.

Nevanac (nepafenac) Ophthalmic Suspension

Date of Approval: August 19, 2005
Company: Alcon, Inc.
Treatment for: Postoperative Ocular Inflammation

Nevanac (nepafenac) is a topical nonsteroidal anti-inflammatory (NSAID) and analgesic prodrug indicated for the treatment of pain and inflammation associated with cataract surgery.

ACTOplus met (pioglitazone and metformin) Tablets

Date of Approval: August 29, 2005
Company: Takeda Pharmaceuticals
Treatment for: Type 2 Diabetes

Actoplus met (pioglitazone and metformin) is a combination antihyperglycemic medication used in the management of type 2 diabetes.

Increlex (mecasermin) Injection

Date of Approval: August 30, 2005
Company: Tercica, Inc.
Treatment for: Primary IGF-1 Deficiency

Increlex (mecasermin) contains human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology. Increlex is indicated for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone.

ProQuad (measles, mumps, rubella and varicella virus vaccine, live) Injection

Date of Approval: September 6, 2005
Company: Merck & Co., Inc.
Treatment for: Mumps Prophylaxis, Measles Prophylaxis, Rubella Prophylaxis, Varicella-Zoster, Prophylaxis

ProQuad (measles, mumps, rubella and varicella virus vaccine, live) is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age.

Angeliq (drospirenone and estradiol) Tablets

Date of Approval: September 28, 2005
Company: Berlex, Inc.
Treatment for: Postmenopausal Symptoms

Angeliq is a hormone replacement therapy containing estradiol and the progestin drospirenone, a hormone that counters the excess water and sodium buildup that is a side effect of estradiol. Angeliq is used to treat moderate to severe menopausal symptoms, such as hot flashes and vaginal dryness.

Flexbumin (albumin human) Solution

Date of Approval: October 17, 2005
Company: Baxter Healthcare Corporation
Treatment for: Plasma Volume Expansion

Flexbumin (albumin human) is the first human serum albumin preparation packaged in a flexible container (previously packaged in glass bottles). Flexbumin is indicated in hypovolemia, hypoalbuminemia due to inadequate reproduction, excessive catabolism, hemorrhage, major surgery or burns, and for use during cardiopulmonary bypass surgery.

Arranon (nelarabine) Injection

Date of Approval: October 28, 2005
Company: GlaxoSmithKline
Treatment for: Acute Lymphoblastic Leukemia, Lymphoma

Arranon (nelarabine) is a chemotherapy agent indicated for the treatment of adults and children with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

Soltamox (tamoxifen) Oral Solution

Date of Approval: October 29, 2005
Company: Savient Pharmaceuticals, Inc.
Treatment for: Breast Cancer

Soltamox is an oral liquid formulation of tamoxifen indicated for the treatment of breast cancer.

Exjade (deferasirox) Dispersible Tablets

Date of Approval: November 2, 2005
Company: Novartis
Treatment for: Hemosiderosis, Iron Overload

Exjade (deferasirox) is a once-daily oral iron chelator approved for the treatment of chronic iron overload due to blood transfusions, and non-transfusion-dependent thalassemia.

Hylenex (hyaluronidase) Injection - formerly Enhanze SC

Date of Approval: December 2, 2005
Company: Halozyme Therapeutics/Baxter Healthcare Corporation
Treatment for: Adjuvant Agent to Enhance Drug Delivery

Hylenex recombinant is a purified preparation of the enzyme recombinant human hyaluronidase, indicated for use as an adjuvant agent 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.

iPlex (mecasermin rinfabate [rDNA origin]) Injection - formerly SomatoKine

Date of Approval: December 12, 2005
Company: Insmed Incorporated
Treatment for: Primary IGF-1 Deficiency

iPlex (mecasermin rinfabate) is the human recombinant of the naturally occurring protein complex of insulin-like growth factor-I (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3). iPlex is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

Nexavar (sorafenib) Tablets

Date of Approval: December 20, 2005
Company: Bayer Pharmaceuticals Corporation
Treatment for: Renal Cell Carcinoma, Hepatocellular Carcinoma, Thyroid Cancer

Nexavar (sorafenib) is an oral multi-kinase inhibitor indicated for the treatment of hepatocellular carcinoma, renal cell carcinoma, and thyroid carcinoma.

Orencia (abatacept) Injection

Date of Approval: December 23, 2005
Company: Bristol-Myers Squibb Company
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Graft Versus Host Disease - Prophylaxis

Orencia (abatacept) is a selective T cell costimulation modulator indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and the prophylaxis of acute graft versus host disease (aGVHD).

Revlimid (lenalidomide) Capsules

Date of Approval: December 27, 2005
Company: Celgene Corporation
Treatment for: Myelodysplastic Syndrome, Multiple Myeloma, Lymphoma, Follicular Lymphoma

Revlimid (lenalidomide) is a thalidomide analogue indicated for the treatment of adult patients with:

  • Multiple myeloma (MM), in combination with dexamethasone.
  • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
  • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
  • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
  • Previously treated follicular lymphoma (FL), in combination with a rituximab product.
  • Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

Vaprisol (conivaptan hydrochloride) Injection

Date of Approval: December 29, 2005
Company: Astellas Pharma US, Inc.
Treatment for: Hyponatremia

Vaprisol (conivaptan hydrochloride injection) is an arginine vasopressin antagonist for the treatment of euvolemic and hypervolemic hyponatremia in hospitalized patients.

Xibrom (bromfenac) Ophthalmic Solution

Date of Approval: March 24, 2005
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation

Marketing Status: Discontinued

Xibrom (bromfenac) is an ophthalmic nonsteroidal antiinflammatory drug (NSAID) for the treatment of postoperative pain and inflammation in patients who have undergone cataract extraction.

Revlimid (lenalidomide) Capsules

Date of Approval: December 27, 2005
Company: Celgene Corporation
Treatment for: Myelodysplastic Syndrome, Multiple Myeloma, Lymphoma, Follicular Lymphoma

Revlimid (lenalidomide) is a thalidomide analogue indicated for the treatment of adult patients with:

  • Multiple myeloma (MM), in combination with dexamethasone.
  • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
  • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
  • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
  • Previously treated follicular lymphoma (FL), in combination with a rituximab product.
  • Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

Aptivus (tipranavir) Capsules

Date of Approval: June 22, 2005
Company: Boehringer Ingelheim
Treatment for: HIV Infection

Aptivus (tipranavir) is a non-peptidic protease inhibitor which is co-administered with ritonavir for the treatment of HIV Infection.

Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap))

Date of Approval: June 10, 2005
Company: Aventis Pasteur Limited
Treatment for: Tetanus Prophylaxis, Diphtheria Prophylaxis, Pertussis Prophylaxis

Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)) is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis.

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