New Drug Approvals
osphenea (ospemifene) Tablets
Company: Shionogi Inc.
Date of Approval: February 26, 2013
Treatment for: Dyspareunia
Date of Approval: February 26, 2013
Treatment for: Dyspareunia
Osphena (ospemifene) is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause.
Kadcyla (ado-trastuzumab emtansine) Injection
Company: Genentech, Inc.
Date of Approval: February 22, 2013
Treatment for: Breast Cancer
Date of Approval: February 22, 2013
Treatment for: Breast Cancer
Kadcyla (ado-trastuzumab emtansine) is a HER2-targeted antibody and microtubule inhibitor conjugate indicated for the treatment of patients with HER2-positive, metastatic breast cancer.
Vituz (chlorpheniramine and hydrocodone) Oral Solution
Company: Hawthorn Pharmaceuticals, Inc.
Date of Approval: February 20, 2013
Treatment for: Cough, Cold Symptoms
Date of Approval: February 20, 2013
Treatment for: Cough, Cold Symptoms
Vituz (chlorpheniramine and hydrocodone) Oral Solution is an antihistamine/antitussive combination indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold.
Pomalyst (pomalidomide) Capsules
Company: Celgene Corporation
Date of Approval: February 8, 2013
Treatment for: Multiple Myeloma
Date of Approval: February 8, 2013
Treatment for: Multiple Myeloma
Pomalyst (pomalidomide) is a thalidomide analogue indicated for the treatment of patients with multiple myeloma.
Ravicti (glycerol phenylbutyrate) Oral Liquid
Company: Hyperion Therapeutics
Date of Approval: February 1, 2013
Treatment for: Urea Cycle Disorders
Date of Approval: February 1, 2013
Treatment for: Urea Cycle Disorders
Ravicti (glycerol phenylbutyrate) is a nitrogen-binding agent for the chronic management of patients with urea cycle disorders.
Delzicol (mesalamine) Delayed-Release Capsules
Company: Warner Chilcott (US), LLC
Date of Approval: February 1, 2013
Treatment for: Ulcerative Colitis
Date of Approval: February 1, 2013
Treatment for: Ulcerative Colitis
Delzicol (mesalamine) is an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.
Kynamro (mipomersen) Injection
Company: Genzyme and Isis Pharmaceuticals, Inc.
Date of Approval: January 29, 2013
Treatment for: Homozygous Familial Hypercholesterolemia
Date of Approval: January 29, 2013
Treatment for: Homozygous Familial Hypercholesterolemia
Kynamro (mipomersen) is an oligonucleotide inhibitor of apolipoprotein B-100 synthesis indicated for the treatment of patients with homozygous familial hypercholesterolemia.
Nesina (alogliptin) Tablets - formerly SYR-322
Company: Takeda Pharmaceutical Company Limited
Date of Approval: January 25, 2013
Treatment for: Diabetes Mellitus Type II
Date of Approval: January 25, 2013
Treatment for: Diabetes Mellitus Type II
Nesina (alogliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes.
Oseni (alogliptin and pioglitazone) Tablets - formerly SYR-322/Actos
Company: Takeda Pharmaceutical Company Limited
Date of Approval: January 25, 2013
Treatment for: Diabetes Mellitus Type II
Date of Approval: January 25, 2013
Treatment for: Diabetes Mellitus Type II
Oseni (alogliptin and pioglitazone) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and thiazolidinedione fixed-dose combination for the treatment of type 2 diabetes.
Kazano (alogliptin and metformin) Tablets
Company: Takeda Pharmaceutical Company Limited
Date of Approval: January 25, 2013
Treatment for: Diabetes Mellitus Type II
Date of Approval: January 25, 2013
Treatment for: Diabetes Mellitus Type II
Kazano (alogliptin and metformin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide antihyperglycemic fixed-dose combination for the treatment of type 2 diabetes.
Oxytrol for Women (oxybutynin) Transdermal System
Company: Merck
Date of Approval: January 25, 2013
Treatment for: Overactive Bladder
Date of Approval: January 25, 2013
Treatment for: Overactive Bladder
Oxytrol for Women (oxybutynin) is a muscarinic receptor antagonist transdermal patch available over-the-counter for the treatment of overactive bladder in women.
Zecuity (sumatriptan) Transdermal Patch - formerly Zelrix
Company: NuPathe Inc.
Date of Approval: January 17, 2013
Treatment for: Migraine
Date of Approval: January 17, 2013
Treatment for: Migraine
Zecuity (sumatriptan iontophoretic transdermal system) is a serotonin (5HT) 1b/1d receptor agonist (triptan) indicated for the acute treatment of migraine.
Octaplas (pooled plasma (human)) Solution for Intravenous Infusion
Company: Octapharma
Date of Approval: January 17, 2013
Treatment for: Bleeding
Date of Approval: January 17, 2013
Treatment for: Bleeding
Octaplas is a solvent/detergent (S/D) treated, pooled human plasma indicated for the replacement of multiple coagulation factors in patients with acquired deficiencies and plasma exchange in patients with thrombotic thrombocytopenic purpura.
Flublok (influenza vaccine, recombinant hemagglutinin) Injection
Company: Protein Sciences Corp.
Date of Approval: January 16, 2013
Treatment for: Influenza Prophylaxis
Date of Approval: January 16, 2013
Treatment for: Influenza Prophylaxis
FluBlok (influenza vaccine, recombinant hemagglutinin) is an influenza vaccine indicated for active immunization of adults against seasonal influenza.
Uceris (budesonide) Extended Release Tablets
Company: Santarus, Inc.
Date of Approval: January 14, 2013
Treatment for: Ulcerative Colitis
Date of Approval: January 14, 2013
Treatment for: Ulcerative Colitis
Uceris (budesonide) is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
Fulyzaq (crofelemer) Delayed-Release Tablets
Company: Salix Pharmaceuticals, Ltd.
Date of Approval: December 31, 2012
Treatment for: Diarrhea
Date of Approval: December 31, 2012
Treatment for: Diarrhea
Fulyzaq (crofelemer) is a proanthocyanidin oligomer indicated to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy.
Eliquis (apixaban) Tablets
Company: Bristol-Myers Squibb Company and Pfizer Inc.
Date of Approval: December 28, 2012
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation
Date of Approval: December 28, 2012
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation
Eliquis (apixaban) is a factor Xa inhibitor anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Reference: http://www.drugs.com/newdrugs.html
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