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New Drug Approvals Archive - January 2013

January 2013

January 8	Kineret (anakinra) New Indication Approved: December 21, 2012 FDA approves Kineret for the treatment of NOMID
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. U.S. FDA Approves Bayer's Skyla (Levonorgestrel-Releasing Intrauterine System) 13.5 mg For Prevention Of Pregnancy For Up To Three Years Skyla (levonorgestrel) FDA Approval History
January 14	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. Santarus Receives FDA Approval of Uceris (budesonide) for the Induction of Remission in Patients with Active, Mild to Moderate Ulcerative Colitis Uceris (budesonide) FDA Approval History
January 16	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 . FDA Approves Flublok - New Seasonal Influenza Vaccine Made Using Novel Technology Flublok (influenza vaccine) 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. FDA Approves Octaplas to Treat Patients with Blood Clotting Disorders Octaplas (pooled plasma (human)) FDA Approval History
January 18	Botox (onabotulinumtoxinA) New Indication Approved: January 18, 2013 FDA Approves Botox to Treat Overactive Bladder
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. NuPathe's Zecuity Approved by the FDA for the Acute Treatment of Migraine Zecuity (sumatriptan) FDA Approval History
January 23	Exjade (deferasirox) New Indication Approved: January 23, 2013 FDA Approves Exjade to Remove Excess Iron in Patients with Genetic Blood Disorder Exjade (deferasirox) FDA Approval History
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
October 8	Uceris (budesonide) New Dosage Form Approved: October 8, 2014 FDA Approves Uceris (budesonide) Rectal Foam for Ulcerative Colitis Uceris (budesonide) FDA Approval History
October 29	Flublok (influenza vaccine) Patient Population Altered: October 29, 2014 Flublok Influenza Vaccine Now Approved for Adults Ages 18 and Older Flublok (influenza vaccine) FDA Approval History
June 23	Flublok (influenza vaccine) New Formulation Approved: June 23, 2016 FDA Approved Longer Shelf Life for the Game Changer, Flublok Influenza Vaccine Flublok (influenza vaccine) FDA Approval History
October 11	Flublok (influenza vaccine) New Formulation Approved: October 7, 2016 FDA Approves Flublok Quadrivalent Influenza Vaccine Flublok (influenza vaccine) FDA Approval History

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