New Drug Approvals Archive

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January 2013

January 8

Kineret (anakinra)

New Indication Approved: December 21, 2012

January 9

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.

Skyla (levonorgestrel) FDA Approval History

January 14

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.

Uceris (budesonide) FDA Approval History

January 16

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.

Flublok (influenza vaccine, recombinant hemagglutinin) FDA Approval History

January 17

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.

Octaplas (pooled plasma (human)) FDA Approval History

January 18

Botox (onabotulinumtoxinA)

New Indication Approved: January 18, 2013

January 17

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.

Zecuity (sumatriptan) FDA Approval History

January 23

Exjade (deferasirox)

New Indication Approved: January 23, 2013

Exjade (deferasirox) FDA Approval History

January 25

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

Patient Population Altered: January 25, 2013

Prevnar 13 (pneumococcal 13-valent conjugate vaccine) FDA Approval History

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.

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.

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.

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.

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.

Kynamro (mipomersen) FDA Approval History

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