Relistor (methylnaltrexone bromide) Subcutaneous Injection
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.
Aplenzin (bupropion hydrobromide) Extended-Release Tablets - formerly BVF-033
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.
Cimzia (certolizumab pegol) Injection
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.
Treximet (sumatriptan succinate and naproxen sodium) Tablets - formerly Trexima
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
Patanase (olopatadine hydrochloride) Nasal Spray
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.
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.
Rotarix (rotavirus vaccine, live attenuated)
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.
Treanda (bendamustine hydrochloride) Injection
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).
Artiss (fibrin sealant (human)) Frozen solution and lyophilized powder for solution for topical application
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.
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.
Pristiq (desvenlafaxine) Extended-Release Tablets
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.
Arcalyst (rilonacept) - formerly Interleukin-1 Trap
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).
Xyntha (antihemophilic factor (recombinant), plasma/albumin free )
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.
Simcor (niacin ER and simvastatin) Tablets
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.
Accretropin (somatropin (rDNA origin)) Subcutaneous Injection
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.
Moxatag (amoxicillin) Extended Release Tablets - formerly Amoxicillin PULSYS
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).
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.
Intelence (etravirine) Tablets - formerly TMC125
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.
