List of drugs 2013 FDA

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 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


January 17

January 25

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

Patient Population Altered: January 25, 2013
January 25

Gleevec (imatinib mesylate)

Patient Population Altered: January 25, 2013
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.
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.
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.
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.
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.

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