Date of Approval: April 25, 2008
Company: Progenics Pharmaceuticals, Inc. and Wyeth Pharmaceuticals
Treatment for: Opioid-Induced Constipation
Relistor is a peripherally acting mu-opioid receptor antagonist indicated to treat opioid-induced constipation.
- Progenics and Wyeth Announce FDA Has Approved Relistor - April 25, 2008
- Progenics and Wyeth Announce NDA Review Period for Subcutaneous Methylnaltrexone Extended by Three Months - January 10, 2008
- Progenics and Wyeth Announce FDA Has Accepted For Filing the New Drug Application for Subcutaneous Methylnaltrexone - May 31, 2007
- Progenics and Wyeth Announce Submission of New Drug Application for the Subcutaneous Formulation of Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Patients Receiving Palliative Care - March 30, 2007
Date of Approval: April 23, 2008
Company: Biovail Corporation
Treatment for: Depression
Aplenzin is a once-daily formulation of bupropion hydrobromide indicated for the treatment of depression in adults.
- Biovail Receives FDA Approval for Aplenzin (BVF-033) - April 24, 2008
Date of Approval: April 22, 2008
Company: UCB, Inc.
Treatment for: Crohn's Disease -- Acute
Cimzia is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of moderately to severely active Crohn’s disease in adults.
- Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease - April 22, 2008
- FDA Agrees to Review Cimzia File for the Treatment of Rheumatoid Arthritis - February 6, 2008
- UCB Provides Update on Cimzia for Crohn's Disease and Rheumatoid Arthritis in the US - March 23, 2007
- UCB Submits Biologics License Application to FDA for New Treatment in Crohn's Disease - March 2, 2006
Date of Approval: April 15, 2008
Company: Pozen Inc.
Treatment for: Migraine
Treximet is a combination of sumatriptan (a migraine-specific triptan) and naproxen (an anti-inflammatory pain reliever) in a single tablet for the acute treatment of migraine.
- Treximet (sumatriptan and naproxen sodium) Tablets Approved by FDA for Acute Treatment of Migraine - April 16, 2008
- Pozen Submits Human Lymphocyte Study for Treximet (Formerly Known as Trexima) - January 16, 2008
- Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA - November 1, 2007
- Pozen Submits Response to Approvable Letter for Trexima - October 15, 2007
- Pozen Plans to Submit Response to Approvable Letter For Trexima Within the Next Ten Days - October 5, 2007
- FDA Issues Second Approvable Letter for Trexima - August 2, 2007
- Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA - March 22, 2007
- Pozen Expects to Submit Revised Response to Trexima Approvable Letter by Year End - December 13, 2006
- Pozen Submits Full Response to FDA Approvable Letter For Trexima - November 9, 2006
- Pozen to Submit Full Response to Trexima Approvable Letter During the Fourth Quarter - July 31, 2006
- Pozen Inc. and GlaxoSmithKline Report Receipt of Approvable Letter for Investigational Migraine Treatment - June 9, 2006
- GlaxoSmithKline and POZEN Announce Trexima (Sumatriptan Succinate and Naproxen Sodium) New Drug Application Accepted for Review by FDA - October 11, 2005
- POZEN Submits New Drug Application for Trexima (Sumatriptan Succinate and Naproxen Sodium) for the Acute Treatment of Migraine - August 8, 2005
Date of Approval: April 15, 2008
Company: Alcon, Inc.
Treatment for: Allergic Rhinitis
Patanase (olopatadine) is an antihistamine nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and adolescents twelve years of age and older.
- Alcon's Patanase Nasal Spray Approved by FDA for Treatment of Nasal Allergy Symptoms - April 16, 2008
- Alcon Amends NDA for Patanase Nasal Spray - October 11, 2007
Date of Approval: April 10, 2008
Company: CV Therapeutics, Inc.
Treatment for: Pharmacologic Stress Agent in Radionuclide Myocardial Perfusion Imaging
Lexiscan (regadenoson) is an A2A adenosine receptor agonist indicated for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging (MPI), a test that detects and characterizes coronary artery disease, in patients unable to undergo adequate exercise stress.
- CV Therapeutics and Astellas Announce FDA Approval for Lexiscan (regadenoson) Injection - April 11, 2008
Date of Approval: April 3, 2008
Company: GlaxoSmithKline
Treatment for: Prevention of Rotavirus Gastroenteritis
Rotarix is an oral, two-dose, live attenuated vaccine for the prevention of rotavirus gastroenteritis in children.
- FDA Approves Rotarix Vaccine to Prevent Gastroenteritis Caused by Rotavirus - April 4, 2008
- GSK Receives Favorable Recommendation by FDA Advisory Committee for Rotarix (Rotavirus Vaccine, Live, Oral) - February 20, 2008
- GlaxoSmithKline's Application for Rotarix is Accepted for Review by the FDA - August 14, 2007
- AVANT's Partner, GlaxoSmithKline, Files Rotarix Application for U.S. Marketing Approval with the FDA - June 27, 2007
Date of Approval: March 20, 2008
Company: Cephalon, Inc.
Treatment for: Chronic Lymphocytic Leukemia
Treanda (bendamustine) is a purine alkylator hybrid chemotherapy agent indicated for the treatment of patients with chronic lymphocytic leukemia (CLL).
- Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic Lymphocytic Leukemia - March 20, 2008
- FDA Accepts Treanda New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma - February 19, 2008
- Cephalon Submits New Drug Application for Treanda for the Treatment of Patients with Relapsed Indolent Non-Hodgkin's Lymphoma - January 2, 2008
- Treanda New Drug Application for the Treatment of Chronic Lymphocytic Leukemia Granted Priority Review Status by FDA - December 3, 2007
- Cephalon Submits New Drug Application for Treanda for the Treatment of Chronic Lymphocytic Leukemia - September 21, 2007
- Cephalon Announces Plans for New NDA Filing for Treanda - June 28, 2007
Date of Approval: March 19, 2008
Company: Baxter Healthcare Corporation
Treatment for: Burns - External
Artiss (fibrin sealant (human)) is a slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients.
- FDA Approves Artiss Medical Adhesive to Treat Burn Patients - March 19, 2008
Date of Approval: March 7, 2008
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Folic Acid Antagonist Overdose, Methotrexate Rescue
Levoleucovorin is a folate analog and the pharmacologically active isomer of calcium leucovorin. Levoleucovorin rescue is used after the administration of high-dose methotrexate in osteosarcoma. Levoleucovorin is also used to treat inadvertent overdosage of folic acid antagonists.
- FDA Approves New Drug Application for Levoleucovorin, Spectrum's First Proprietary Oncology Drug - March 10, 2008
- FDA Accepts ISO-Vorin New Drug Application Amendment Submitted by Spectrum Pharmaceuticals - September 13, 2007
- Spectrum Pharmaceuticals Completes the NDA Filing for Isovorin - July 2, 2007
Date of Approval: February 29, 2008
Company: Wyeth Pharmaceuticals
Treatment for: Depression
Pristiq (desvenlafaxine) is a serotonin-norepinephrine reuptake inhibitor (SNRI) approved for the treatment for adult patients with major depressive disorder. Pristiq is also currently under review as a treatment for moderate-to-severe vasomotor symptoms associated with menopause.
- FDA Approves Pristiq for the Treatment of Adult Patients with Major Depressive Disorder - March 3, 2008
- Wyeth Receives Approvable Letter from FDA for Pristiq for the Treatment of Vasomotor Symptoms Associated with Menopause - July 24, 2007
- Wyeth Receives Approvable Letter From FDA for Pristiq (Desvenlafaxine Succinate) for the Treatment of Major Depressive Disorder - January 23, 2007
- Re-formatted Data Submission Results in Extension of FDA Review for Desvenlafaxine Succinate - August 29, 2006
- FDA Cancels Advisory Committee Meeting to Review Desvenlafaxine Succinate Data for Major Depressive Disorder - August 22, 2006
- Wyeth Submits Two New Drug Applications for Women's Health Therapies - June 26, 2006
- Wyeth Submits New Drug Application for Desvenlafaxine Extended Release (DVS-233) for Depression - December 22, 2005
Date of Approval: February 27, 2008
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Cryopyrin-Associated Periodic Syndromes
Arcalyst (rilonacept) is an interleukin-1 inhibitor for the long-term treatment of Cryopyrin-Associated Periodic Syndromes (CAPS).
- FDA Approves Arcalyst - New Orphan Drug for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) - February 28, 2008
- PDUFA Date for Rilonacept (IL-1 Trap) Extended Three Months by FDA - November 2, 2007
- Rilonacept (IL-1 Trap) Granted FDA Priority Review for the Treatment of CAPS - August 8, 2007
- Regeneron Submits Biologics License Application to U.S. FDA for IL-1 Trap (Rilonacept) for Treatment of CAPS - June 8, 2007
Date of Approval: February 21, 2008
Company: Wyeth Pharmaceuticals Inc.
Treatment for: Hemophilia A
Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Xyntha is indicated for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A.
- FDA Licenses Xyntha, a New Hemophilia Treatment - February 21, 2008
Date of Approval: February 15, 2008
Company: Abbott
Treatment for: Hyperlipidemia
Simcor (Niaspan/simvastatin) is a fixed-dose combination lipid therapy used along with diet to lower levels of total cholesterol, LDL "bad" cholesterol and triglycerides, and to increase HDL "good" cholesterol.
- Abbott Receives FDA Approval for Simcor (Niaspan / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management - February 19, 2008
- Abbott and Solvay Pharmaceuticals to co-promote Abbott's Simcor in the United States - October 22, 2007
- Abbott Submits New Drug Application for Simcor Combination Niaspan/Simvastatin Tablet - April 20, 2007
Date of Approval: January 23, 2008
Company: Cangene
Treatment for: Pediatric Growth Hormone Deficiency, Turner's Syndrome
Accretropin (somatropin (rDNA origin)) is recombinant human growth hormone indicated for treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone, or treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed.
- Cangene's Recombinant Human Growth Hormone Accretropin Approved by the U.S. Food and Drug Administration - January 25, 2008
- Cangene Receives an Approvable Letter From the FDA for Human Growth Hormone - March 12, 2007
- Cangene’s Human Growth Hormone Drug Submission is Accepted for Review by FDA - July 17, 2006
Date of Approval: January 23, 2008
Company: MiddleBrook Pharmaceuticals, Inc.
Treatment for: Tonsillitis/Pharyngitis
Moxatag is a once-daily extended-release formulation of the penicillin antibiotic amoxicillin indicated for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (commonly referred to as strep throat).
- FDA Approves MiddleBrook's Moxatag - Amoxicillin PULSYS - for Pharyngitis/Tonsillitis in Adolescents and Adults - January 24, 2008
- Advancis Pharmaceutical Announces FDA Acceptance of Amoxicillin PULSYS NDA - May 22, 2007
- Advancis Pharmaceutical Resubmits New Drug Application for Once-Daily Amoxicillin PULSYS - March 24, 2007
Date of Approval: January 18, 2008
Company: Novartis Pharmaceuticals Corporation
Treatment for: Hypertension
Tekturna HCT (aliskiren and hydrochlorothiazide) is a single-tablet combination therapy for the treatment of high blood pressure.
- Tekturna HCT, a Single-Tablet Combination of Tekturna and a Diuretic, Receives US Approval for Treatment of High Blood Pressure - January 22, 2008
- Single-Tablet Combination of Tekturna and Diuretic, an Important New Option for People With High Blood Pressure, Accepted for Review in U.S. - May 21, 2007
Date of Approval: January 18, 2008
Company: Tibotec Pharmaceuticals Ltd.
Treatment for: HIV Infection
Intelence (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients.
- FDA Approves Intelence (etravirine) for HIV Combination Therapy - January 22, 2008
- FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125 - September 20, 2007
- New Drug Application for Investigational HIV Treatment TMC125 Submitted to U.S. Food and Drug Administration - July 18, 2007
