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New Drug Approvals Archive - January 2013

January 2013

Kineret (anakinra)

New Indication Approved: December 21, 2012

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.

Read more: Skyla (levonorgestrel) FDA Approval History

Uceris (budesonide)

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.

Read more: Uceris (budesonide) FDA Approval History

Flublok (influenza vaccine) 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 against seasonal influenza in adults 18 years of age and older .

Read more: Flublok (influenza vaccine) FDA Approval History

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.

Read more: Octaplas (pooled plasma (human)) FDA Approval History

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.

Read more: Zecuity (sumatriptan) FDA Approval History

Gleevec (imatinib mesylate)

Patient Population Altered: January 25, 2013

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.

Read more: Oxytrol for Women (oxybutynin) FDA Approval History

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.

Read more: Nesina (alogliptin) FDA Approval History

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.

Read more: Oseni (alogliptin and pioglitazone) FDA Approval History

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.

Read more: Kazano (alogliptin and metformin) FDA Approval History

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.

Read more: Kynamro (mipomersen) FDA Approval History

Flublok (influenza vaccine)

New Formulation Approved: October 7, 2016

Read more: Flublok (influenza vaccine) FDA Approval History

New Drug Approvals Archive