List of drugs 2013 FDA

 FDA DOWNLOAD

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM381803.pdf

January 2013

 

Kineret (anakinra)

New Indication Approved: December 21, 2012 

FDA approves Kineret for the treatment of NOMID

Skyla (levonorgestrel) Intrauterine System

Date of Approval: January 9, 2013
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Contraception

Skyla (levonorgestrel) is a progestin-containing intrauterine system (IUS) indicated for prevention of pregnancy for up to three years.

 

Uceris (budesonide) Extended Release Tablets

Date of Approval: January 14, 2013
Company: Santarus, Inc.
Treatment for: Ulcerative Colitis

Uceris (budesonide) is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis

 

Flublok (influenza vaccine, recombinant hemagglutinin) Injection

Date of Approval: January 16, 2013
Company: Protein Sciences Corp.
Treatment for: Influenza Prophylaxis

FluBlok (influenza vaccine, recombinant hemagglutinin) is an influenza vaccine indicated for active immunization of adults against seasonal influenza.

 

Octaplas (pooled plasma (human)) Solution for Intravenous Infusion

Date of Approval: January 17, 2013
Company: Octapharma
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.

Botox (onabotulinumtoxinA)

New Indication Approved: January 18, 2013

Zecuity (sumatriptan) Transdermal Patch - formerly Zelrix

Date of Approval: January 17, 2013
Company: NuPathe Inc.
Treatment for: Migraine

Zecuity (sumatriptan iontophoretic transdermal system) is a serotonin (5HT) 1b/1d receptor agonist (triptan) indicated for the acute treatment of migraine.

Exjade (deferasirox)

New Indication Approved: January 23, 2013

• FDA Approves Exjade to Remove Excess Iron in Patients with Genetic Blood Disorder

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January 17
January 25	Prevnar 13 (pneumococcal 13-valent conjugate vaccine) Patient Population Altered: January 25, 2013 Pfizer Receives FDA Approval For The Use Of Prevnar 13 In Vaccine-Naive Children And Adolescents Aged 6 Years Through 17 Years For The Prevention Of Invasive Pneumococcal Disease Prevnar 13 (pneumococcal 13-valent conjugate vaccine) FDA Approval History
January 25	Gleevec (imatinib mesylate) Patient Population Altered: January 25, 2013 FDA Approves Gleevec for Children with Acute Lymphoblastic Leukemia
January 25	Oxytrol for Women (oxybutynin) Transdermal System Date of Approval: January 25, 2013 Company: Merck 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. FDA Approves Over-the-Counter Oxytrol for Women to treat Overactive Bladder Oxytrol for Women (oxybutynin) FDA Approval History
January 25	Nesina (alogliptin) Tablets - formerly SYR-322 Date of Approval: January 25, 2013 Company: Takeda Pharmaceutical Company Limited  Treatment for: Diabetes Type 2 Nesina (alogliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes. Takeda Receives FDA Approval for Nesina (alogliptin) for Type 2 Diabetes Nesina (alogliptin) FDA Approval History
January 25	Oseni (alogliptin and pioglitazone) Tablets - formerly SYR-322/Actos Date of Approval: January 25, 2013 Company: Takeda Pharmaceutical Company Limited Treatment for: Diabetes Type 2 Oseni (alogliptin and pioglitazone) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and thiazolidinedione fixed-dose combination for the treatment of type 2 diabetes. Takeda Receives FDA Approval for Oseni (alogliptin and pioglitazone) for Type 2 Diabetes Oseni (alogliptin and pioglitazone) FDA Approval History
January 25	Kazano (alogliptin and metformin) Tablets Date of Approval: January 25, 2013 Company: Takeda Pharmaceutical Company Limited Treatment for: Diabetes Type 2 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. Takeda Receives FDA Approval for Kazano (alogliptin and metformin) for Type 2 Diabetes Kazano (alogliptin and metformin) FDA Approval History
January 29	Kynamro (mipomersen) Injection Date of Approval: January 29, 2013 Company: Genzyme and Isis Pharmaceuticals, Inc. 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. FDA Approves New Orphan Drug Kynamro to Treat Inherited Cholesterol Disorder Kynamro (mipomersen) FDA Approval History